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Meeting report

2nd International New Technologies and Expert Meeting (Part 2)

Summary of the Second International New Technologies and Expert Meeting

In 2015, the Non Inva Meeting has transformed itself into the 1st New Technologies and Expert International Meeting. We were happy to welcome again friends in Lyon and to continue to deliver state of the art expertise and a focus on innovative technologies in the bariatric field. The general theme of this 2017 meeting has dealt with weight-loss trajectories after bariatric interventions: Can they be improved? For a given intervention, is there a specific trajectory (or a set of trajectories) that can be well defined, i.e. a "signature".

By Jerome Dargent Co-Chairman, Non-Inva/New Technologies and Expert International Meeting

Organising such a meeting has become a challenge over the past few years. We are still convinced that while bigger meetings are important, more focus on key-issues and more discussion with a perspective are provided in smaller reunions. Times have changed, and there is nobody to blame for this. The industry has reduced is support, and new regulations have made it difficult for physicians to attend meetings abroad. We will continue to discuss the strategy with the companies designing new materials, while staying optimistic: innovative devices are implemented every year, and need a thorough evaluation, particularly in the endoscopic field.

Bariatric endoscopy

Overview of current balloons (pros and cons, trials, etc.)
Presented by Gontrand Lopez-Nava (Spain)

One estimates that 20% of the obese patients are non-responders to gastric balloon. We must take into account the two mechanisms of the balloon: restriction and delayed gastric emptying. On one hand, restriction is not necessarily related to the volume of the balloon: for example, the duo-balloon has a double volume compared to the usual ORBERA (900 cc instead of 500), but in a multicentre study the weight-loss has been 8 kg +/- 5.8 only.

On the other hand, food retention tests show usually a 20% rate at 2 hours, after balloon the rate is 61.8% at 8 weeks, 62% at 16 weeks, 30% at 27 weeks. Pre-operative tests could solve the problem of indications. 25% of the patients have a rapid emptying, and therefore benefit from a balloon, 25% have a slow emptying and could preferably have an endoscopic plication.

The Spatz balloon had a 58% EWL in 227 patients, with 6.6% food intolerance, and 12/15 patients saved from early extraction thanks to a 100 cc extraction. Upward adjustments have been possible. Elipse balloon: 40% of the balloons only have been retrieved by the patients; the mean duration of stay has been 117 days +/- 14.

Our criteria for eligible balloons: freely moving; no sharp tips; liquid filled.

Overview of current FDA trials in bariatric endoscopy
Presented by Shelby Sullivan (USA)

This presentation points out the difficulties encountered during FDA trials, according to various goals and guide-lines. Important issue: the rate of responders, differing by study: 25% EWL or 5% TBWL, or 10%? 35 to 50% of the patients have been responders according to these numbers. The study design affects the outcomes, particularly regarding Lifestyle Therapy groups: it can be low, moderate or high, up to 16 sessions in 6 months. The control arm weight-loss becomes essential, as well as the blinding status.

Currently FDA approved endolumenal devices are: ReShape Integrated Dual Balloon System (07/28/2015), Orbera Intragastric Balloon (08/05/2015), Aspire Assist System (06/14/2016), Obalon Ballon System (09/08/2016), Overstitch (08/18/2009), approved as "tissue approximation". Ongoing: Transpyloric System (BARONova), pivotal trial, enrolment completed; Elipse Intragastric Balloon (Allurion), initiating pivotal trial; ValenTx Endoluminal bypass, initiating pivotal trial; EndoBarrier (GI Dynamics), pivotal trial halted, new trial in development, Incisionless Operating Platform for POSE (USGI Medical), approved for POSE as tissue approximation, new trial in development.

FDA approval criteria: Non SAE and SAE, efficacy: % difference in weight loss (Active group Vs Control group), responder rate in the active group compared with benchmark: 35-50% of patients responding, different by studies, the rate differing also (25% EWL, 5% TBWL or 10% TBWL).

Lifestyle therapy: low intensity (<6 sessions in 6 months, no expected weight loss), moderate intensity (6-13 sessions in 6 months, 5% TBWL for completers), high intensity (>14 sessions in 6 months, up to 10% TBWL for completers). This affects the results of the control (lifestyle) group, i.e. responder rate. TBWL in control arm: from 1.3% in POSE pivotal trial, to 4.7% with Orbera, 4.9% with AspireAssist (PATHWAY Trial), 3.6% with Obalon (SMART) and ReShape (REDUCE). Blinding status: patients who know their study assignment tend to lose more weight in the Active Arm (up to 40% more), and have a higher drop rate in the Control arm; unblinded study control group completers have better weight loss than blinded study control group completers.

Is endoscopy really necessary for the placement of a balloon?
Presented by Elisabeth Mathus-Vliegen (The Netherlands)

Admittedly, an endoscopic screening is necessary to detect contra-indications to the placement of an intra gastric balloon: large hiatal hernia (> 3 cm), Grade C or D oesophagitis, gastric peptic ulceration, oesophageal and gastric varices, gastric emptying disturbances. Removal of balloon: clear fluids for 1-2 days Balloon deflation. In order to prove that balloon positioning without endoscopy after a detailed medical history is safe, we did a retrospective analysis to correlate endoscopic findings upon balloon placement to patient history. There were 253 patients in cohort 1(70 M/ 183 F), 36.4 years (15-70), 139.5 kg (93-222), BMI 47.0 (31.1-86.2). There were 50 patients in cohort 2 (8 M/42F), age 35.8 (20-54), 140.0 kg (101-206), BMI 46.0 (33.8-61.7). Patients who opted for surgery after complete balloon work-up, N=57. Patients had both endoscopy and X-ray with contrast.  Six (11%) patients had HH. Findings upon balloon removal: In cohort 1(N= 151), there were 11.9% gastric erosions, 7.9% esophagitis, 1.3% ulcer, 7.3% hiatal hernia; in cohort 2 (N= 43), respectively 0%, 0%, 9.3%, 7%, 0%. Intolerance without specific findings occurred in 2.6% and 4.7%. A careful history prior to intragastric balloon placement can pose contra-indications for balloon placement. Endoscopy prior to balloon placement does not predict complications during balloon therapy. Intragastric balloons can be safely placed after a careful screening history using fluoroscopic guidance. When patients report the presence of a hiatal hernia, an X-ray with contrast may be preferred over endoscopy. Endoscopy is not needed prior to balloon placement, but still needed for removal of these types of balloons with sometimes severe complications.

The original Australian balloon, "Swallow it and forget it"
Presented by Tony
Kierath (Australia)

The early idea of a balloon with a foam filling agent had been presented in this meeting three years ago, there is now a prototype that has been explained.

The balloon, actually a device that presents itself like a bag or a parcel, is swallowed in a GP's office. It is an acid stable and gas permeable material, containing 2 parts with foam, mixed before ingestion, then expanding spontaneously within the stomach. The foam filling prevents deflation. A novel fluoropolymer membrane has been designed, with a low density silicone foam composition, and the shape has been reengineered to maximize the occupied volume and facilitate extraction if needed. The author is awaiting approval from Ethic Committee for initiation of a safety and efficacy long term trial. An application has been made for the customary period of time of the usual balloons, i.e. around 6 months, although this device could be much more a long-standing one.

Consensus treatment for sleeve gastrectomy leaks/ Pigtail drainage, when and how long
Presented by Gianfranco Donatelli (France), and
Julien Branche (France)

When a leak occurs after sleeve gastrectomy, surgical or radiological drainage of the collection associated with stent deployment is still the most frequent treatment around the world, with a fully or a partially covered stents, and always with an external drainage. It has several shortcomings: migration, not water-tight, breaks, problems of ingrowth tissue, and it applies a radial force with secondary ischemia.

Leaks following LSG were treated in our experience with deployment of double pigtail plastic drains across the leak's orifice, positioning one end inside the collection and the other end in remnant stomach. The aim of EID is to internally drain the collection and at the same time promote leak healing. Some patients developed stenosis treated endoscopically. EID achieves complete drainage of perigastric collections and stimulates mucosal growth over the stent. EID is combined with enteral nutrition for 4 weeks, with a first control at 4 weeks. It is changed every 4 months, with a normal alimentation. It achieves an internal fistula, allowing to remove rapidly all external drainage, in order to avoid re-epithelialization of the fistula track. Key-points: tissue re-growth, mobilization of surgical drainage, pseudo-diverticulae. Wait at least one week after surgical drainage before placing an EID.

Rescuing the Endo-Barrier, the leading metabolic endoscopic procedure
Presented by Jan Greve (The Netherlands)

More than 3000 implants have been placed worldwide. The FDA Trial is on hold, mainly because of the occurrence of 7 cases of liver abscess in 217 patients (3.2%). In the German Registry, with 243 patients included, and 12 months data, EWL was 29%, with 3 (1.7%) hepatic abscesses. Hepatic abscess may be treated by antibiotics/drainage/partial resection of the liver (2 cases only).

Total SAE: 6%. 2009-2015 (2904 pts): 22 hepatic abscesses (0.76%), 26 liner obstruction (0.9%), 50 major bleeding (1.72%), 39 migration (1.34%), 15 pancreatitis (0.52%), 7 perforation (0.25%), 10 surgical removal (0.34%), total 169 (5.82%).

The Revise Diabesity study, UK, has been an Open label, multicentre study, with parallel groups: 22 pts EB+Liraglutide Vs 24 EB Vs 22 Liraglutide RCT: EB + 1.2 mg liraglutide.

In a study published in Obes Surg. 2017, Endobarrier in Grade I Obese Patients with Long-Standing Type 2 Diabetes: Role of Gastrointestinal Hormones in Glucose Metabolism, Vilarrasa N et al evaluated the efficacy and safety of the device in grade 1 obese T2DM patients with poor metabolic control, and the role of gastro-intestinal hormone changes on the metabolic outcomes. Twenty-one patients aged 54.1 , diabetes duration 14.8 ± 8.5 years, BMI 33.4 , and HbA1c 9.1 ± 1.3 %, under insulin therapy, were implanted. Patients lost 14.9 ± 5.7 % of their total body weight. HbA1c decreased 1.3 % in the first month, but at the end of the study, the reduction was 0.6 %. HbA1c ≤ 7 % was achieved in 26.3 % of patients. No differences in GLP-1 AUC values were found before and after implant. Fasting plasma ghrelin and PYY concentrations increased from month 1 to 12. Conversely, fasting plasma glucagon concentrations decreased at month 1 and increased thereafter. Minor adverse events occurred in 14 % of patients and major events in 9.5%.

Gastric Endoscopic Plication as a routine, The New York experience
Presented by Reem Sharaiha (USA)

Ten patients have been operated on at the Cornell institute (unpublished). The impact on stomach length has been studied: 20 cm post-op on average Vs 45 cm pre-op. Comparison to surgery in the same hospital (New York Presbyterian): TBWL at 12 months was 29.28% with LSG (mean BMI 47.3, 120 pts), 14.73% with LAGB (BMI 45.07, 67 patients), and 17.57% with ESG (BMI 38.82, 91 patients). Adverse events: 1 leak.

R Sharaihia has also commented on the DDW Abstract 2016: 242 cases in 3 major centers. 1 PMO, 1 PE, 2 seromas. 24 months FU, mean age 44, 73%F, baseline BMI 37.8 +/-5.5. TBWL at 6 months  15%, at 24 months 18.6% (15.7-21.5). The odds of achieving >10% TBWL at 24 months if a patient achieved <10% at 6 months was 0.18. Gastric scintigraphy at 180 min post-meal showed 16% gastric retention, and 45% post-ESG. Changes in satiation on meal tolerance test were also significant.

Gontrand Lopez-Nava has given his own results and answered the question of conversion in case of failure: SADI-S or DS, LSG, and RYGB are the options to consider.

Gastric endoplication with POSE, a reliable and efficient tool for weight loss
Roman Turro-Arau (Spain)

Roman TURRO-ARAU has reported his current experience with the per-oral Incisionless Operating Platform™ (IOP) (USGI Medical) in Spain. It places transmural plications in the gastric fundus and distal body with suture-anchors (the Primary Obesity Surgery Endoluminal [POSE] procedure). Fundus restriction and dismotility in the antrum are created. Best results if BMI<37. Average number of plication= 14. Average time 25 min. SAE =20/5000 (0.4%), Intra gastric bleeding 6, peritoneal abscess 3, extra-gastric bleeding 3, Hepatic abscess 3, gastric perforation 2, pneumoperitoneum 2, Pneumothorax 1.

Published in  Obes Surg (2017:310-322) , the MILEPOST Multicenter Randomized Controlled Trial, by Miller K, Turro R, Greve JW, et al., had the following results: 12-Month Weight Loss and Satiety Outcomes After POSE vs. Medical Therapy.Subjects with class I-II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only. POSE subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months.From November 2013 to July 2014, 44 subjects were randomized (N=34, 77.3 % F; age 38.3 ; BMI 36.5 ) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: POSE, 13.0 % (EWL, 45.0 %), n = 30 Vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). POSE subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred.

Anchors Vs Sutures in endolumenal plication: what evidence do we have?
Presented by Karl Miller (Austria)

Expandable tissue anchors (“snowshoe”) that are specific to the POSE method (USGI) maintain a consistent pressure during post-op healing process, and permit an adjustable cinching for variable tissue thickness, with long-term durability.

Endo-Aspire in a basic setting
Presented by Shelby Sullivan (USA)

With the AspireAssist, patients aspirate gastric contents 20 min after meal consumption, removing about 30% of ingested calories. Aspiration therapy involves endoscopic placement of a gastrostomy tube and the AspireAssist siphon assembly. Premarket FDA has been obtained in June 2014 approval, granting 500 patients for 6 years. US Pivotal Trial: 111 patients Vs 60 with Lifestyle Therapy. At 24 months, EWL was 34% and TBWL 21.4%; at 32 months 39% and 25.5% (44 and 45 kg). Quality of life is increased, anxiety during meals decreased, water consumption during the meals and chewing time increased. No binge eating or excessive eating has been reported, no adverse effect on dietary restraint, body image, etc. No subject showed evidence of worsening eating behaviour.  This method is safe with low SAE, and a 69% overall satisfaction rate. It is easily placed, successful in the long-term in both patients with BMI 35-55 and above 55.

A new device for endo-plication tested in Belgium, the Endomina
Presented by Vincent Huberty (Belgium)

Endoscopic technologies that could reproduce some of the clinical effects of surgery may become part of the obesity treatment armamentarium. A simple transoral restrictive procedure could become a first-line surgical management. The safety and feasibility of transmural suturing has been evaluated. It uses a simple triangulation platform for gastric volume reduction through multiple double plicatures. Between May and July 2015, 11 obese (BMI 34.6 ± 2.1) patients, age 36 ± 10, underwent this procedure. The median duration of the procedure was 2.00 hours (1.15-3.15) and dramatically decreased after the first 5 cases. No SAE were observed. Mean (SD) weight loss and % excess weight loss were 5.8 kg (2.7) and 21% (9) at 1 month (n=11); 8.8 kg (4.9) and 33% (22) at 3 months (n=10); 10.9 kg (7.3) and 41% (33) at 6 months (n=10). The Transoral Endoscopic Gastroplasty appeared safe and effective at mid-term follow-up in creating gastric restriction and inducing weight loss in this first-in-humans experience.

Teaching endoscopy to surgeons: a challenge or an easy way to go?
Presented by Silvana Perretta (Italy)

The digestive and bariatric endoscopy curriculum provided by the IRCAD Institute in Strasburg (France) includes: 100h of E-learning, 50h hands-on, 300h training, 36 lectures, with analysis of complex cases. Transvaginal and transgastric cholecystectomies are performed in the beginning. Flexible and rigid endoscopy, ex vivo and in vivo animal models, and simulators are used. 40 students are registered per year. 90 diplomas have been issued till now. This program has an EAES endorsement. It includes the acquisition of the fundamental knowledge, technical skills, clinical judgement, and allows the validation of a new and hybrid international curriculum.

Endoscopy remains a substantial part of surgery practice. Surgeons are and have been major contributor to the growth and the development of endoscopic methods. A surgical residency training needs to be fully integrated and standardized, with objective measurements of acquired skills and competence. Surgical and GI societies play a major role in shaping up surgical education and granting a “future” to digestive surgeons.

The Elipse Procedureless Gastric Balloon: Global Experience in the First 1000 Patients
Presented by Ram Chuttani (USA)

The Elipse™ intragastric balloon for weight loss (Allurion Technologies Inc., USA) can be swallowed (folded into a capsule), is self-emptying, and excreted. The release valve, only exposed to the inside of the device, opens automatically at 4 months. Being 85% thinner than the average silicone balloon, it is designed to pass the GI tract. 691 Elipse patients (539F), mean age 35.9, mean weight 99.4 ± 10 kg, and mean BMI 36.6 ± 4.8 are presented. For patients through four months of therapy, the mean weight loss was 13.5 kg, mean EWL 54.5%, and mean BMI reduction 5.1. TBWL was 14%. Eleven balloons were removed early due to intolerance. Three bowel obstructions requiring balloon removal occurred, including one in a contraindicated patient with a history of multiple abdominal surgeries. Six empty balloons were vomited uneventfully. This represents a meaningful subset of the approximately 2,300 patients who have received an Elipse balloon and 1,400 who have completed four months of therapy. 

Endoscopic Sleeve Gastroplasty Vs Laparoscopic Gastric Plication Vs Sleeve Gastrectomy: a comparative study
Presented by Amador Garcia Ruiz (Spain)

This non randomized trial is the first of its kind, and makes a sound and relevant comparison between three competitors: Endoscopic Sleeve Gastroplasty (ESG-Overstitch), Laparoscopic Vertical Gastric Plication, and laparoscopic Sleeve Gastrectomy, all achieving a "longitudinal restriction". There were 2 centers in Barcelona, 1 in Madrid.  Enrolment: 66 Vs 69 Vs 38 patients, age 44.4, 59.1% F. Mean BMI 38.5 Vs 40.2 Vs 39.9. CNS 0% Vs 3% Vs 2%; reop 0/1/1. 0 death. EWL% at 6 and 12 months: 6-20 Vs 65-66 Vs 60-65; if BMI <40 22 Vs 25 Vs 34 at 12 month. 30% patients in each group remained with a BMI<30. Endo sleeve: more patients with less than 50%EWL, competes in lower BMI.

Ongoing and upcoming trials in the Czech Republic
Presented by Evzen Machytka (Czech Republic)

Several experimentations have taken place in the Czech Republic, owing to more accommodating conditions to launch a new device. Here are a few examples:

NITINOTES: This device is similar to an Endozip. The automatic deployment of the device makes it non operator-dependant. The tightening takes place under vision, realizing a helicoidal suturing after suction. The shaft is placed along the lesser curvature, at 11 cm distance + 11 more possible.

FRACTYL (see above): REVITA Study in Europe. Randomized, 15 centers and 240 pts; 60 training cases (single arm). Inclusion criteria: HBA1c >7.5%, DT2 >10 years.

GI-WINDOWS, Endoscopic Dual-path Enteral Anastomosis Using Self-Assembling Magnets (see above).

ASPIRE ASSIST (see above).

ENDOMINA (see above).

ENDOSPHERE: several balloons aligned along a catheter and placed within the duodenum (inserted through a guide-wire).

HOURGLASS esogastric band, no longer in trial.

Magnetic satiety-inducing system (no information available so far).

A modern and key-issue in bariatric techniques, cooperation between surgeons and endoscopists: Too close/too far from each other?
Presented by Elisabeth Mathus-Vliegen (The Netherlands)

Several critical issues are shared by surgeons and gastro-enterologists when it comes to obesity: knowledge of the impact of obesity on the digestive tract, the resolution or occurrence / deterioration of obesity-associated diseases by weight loss; Decision of a surgical technique;  Role in pre-operative work-up;  Role in intra-operative endoscopy (debated); Role in post-operative guidance;  Knowledge of altered anatomy; Knowledge of side effects and complications of bariatric surgery; Care of postoperative metabolic complications; Knowledge of the impact of obesity on the digestive tract.

Typical GE conditions include GERD, Barrett’s oesophagus, non-alcoholic fatty liver disease. Obese women carry a twice higher risk of gallbladder disease, less consistent in males. Central obesity is also associated with gallstones in females. Rapid weight loss >1.5 kg/week leads to development of gallstones in 9-33% with symptoms in 10%. Ursochol 600 mg/d for 6 months reduces the risk from 32% to 2%.

In 2005, the European Association of Endoscopic Surgery (EAES) recommended a preoperative evaluation of obesity surgery patients by upper GI series or endoscopy (Grade C), and strongly recommended it for gastric bypass patients (Grade B). The Obesity Society and the American Society for Metabolic and Bariatric Surgery (ASMBS) updated the 2008 Clinical Practice Guideline Screen for H. pylori in high prevalence areas (Grade C), recommended to evaluate gallbladder and liver by ultrasound (Grade D), and clinically significant GI symptoms before bariatric surgery with upper GI series or endoscopy (Grade D). In 2013, the International Federation for the Surgery of Obesity stated that there was no clear indication about the necessity to perform upper GI endoscopy. In 2015, the American Society for Gastrointestinal Endoscopy (ASGE), the Society of Gastrointestinal and Endoscopic Surgeons (SAGES) and American Society for Metabolic and Bariatric Surgery (ASMBS) found that the decision to perform preoperative endoscopy should be individualised and take into consideration the type of the procedure (low quality evidence).  Patients with symptoms of GERD or who use chronically H2 blockers or PPIs should have upper GI endoscopy 2012. In 2016, during the 5th International Consensus Conference on Sleeve gastrectomy, the majority of experts agreed that Barrett’s oesophagus precludes LSG. This means that surgeons should propose a preoperative endoscopy in all their patients. However, this was only done in 1.3%. Moreover, 50% of experts in 2012 agreed that all patients should have pH measurement and manometry before LSG if they complain of reflux.

GI Windows Magnets - endoscopic dual-path enteral anastomosis using self-assembling magnets (First-in-Human Clinical Feasibility, preliminary data
Presented by Evzen Machytka (Czech Republic)

Incisionless Anastomosis System (IAS) creates a minimally invasive incisionless anastomosis and is a fully endoscopic procedure. There is no permanent foreign body, since the device is expelled naturally through the GI tract. One makes a large and robust anastomosis, with no inflammation or scarring that could jeopardize its long-term maintenance. There is no blind loop, a “safety channel” remaining in parallel, with a side-to-side anastomosis. Magnet design: IAS Octagon Configuration, outside diameter is 28 mm, based on 21-25mm circular stapler stricture literature. Ten procedures have been completed, 4F, BMI 41 34.9-47.1), 120 kg (98.5-142), age 48.2 (22-58). Procedure sequences: Endoscopy and colonoscopy are completed, then the endoscopes are removed, magnets loaded into the instrument channel, the endoscopes re-introduced and aligned into the magnet “drop zone” (jejunum and ileum) and coupled. If necessary, a laparoscopic measurement of magnet placement can be useful. Mean duration has been 115 minutes, and dropped 98 in last five. At 6 months there were no SAE. HbA1c dropped from 59.0 mmol/mol at baseline to 38.8 at 24 months.

Similarly to RYGB and BPD, high fat/sugar diets are not well-tolerated but this can be managed with diet. Since pylorus is preserved, there were no events consistent with a dumping syndrome. Early data suggests IAS Diversion procedure is safe, and has a potential mechanism for impact on glycemic indices, independently from weight loss. There was a clinically relevant weight loss at 6 months. Further clinical evaluation is warranted in the diabetic patient population.

BARONova: The Transpyloric Shuttle
Presented by Evzen Machytka (Czech Republic)

The Baronova device consists in a silicone sheath filled with a coiled cord of silicone Placed endoscopically through an overtube. It blocks intermittently the pylorus and remains in the stomach for 12 months. Two cohorts of patients have been included in a prospective nonrandomized open label trial in Sydney, Australia, 3 month implantation: n=10, 6 month implantation: n=10, BMI 30-50. There was a nutrition counseling for low calorie diet given prior to device placement, and no additional lifestyle therapy. The ENDObesity II Trial is a multi-center randomized double-blind sham-controlled trial, with 270 subjects randomized 2:1, 12 month device implantation, BMI 30-40 (BMI 30-34.9: one obesity co-morbidity, BMI 35-40: no co-morbidity required). Lifestyle therapy visits: 7 in person, 4 by phone call. Endoscopies at 2 and 6 months for ulcer surveillance. The enrolment was completed in December 2016, and study completion is expected in December 2017. No data will be available until study completed.

Please click here to read Part 1 and the Non-Inva Report or here to read Part 3

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