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Study approval

USGI to launch ESSENTIAL endoscopic incisionless trial

The 'POSE@ procedure places tissue anchors across folds of tissue in strategically-located parts of the stomach to reduce its size and ability to stretch to accommodate a meal
European outcomes from the POSE procedure show excess weight loss of 62% and total body weight loss of 19%

USGI Medical has obtained conditional approval of its investigational device exemption (IDE) application from the FDA to launch what the company believes to be the largest multicentre, randomised, sham-controlled study of an endoscopic procedure for weight loss ever conducted. The company plans to enrol approximately 350 subjects at up to nine centres across the US in the ESSENTIAL trial.

"Although published data show significantly superior weight loss results from bariatric surgery than from diet and exercise alone, a major open or laparoscopic operation still poses risks and longer recovery times, and surgery is not right for every patient," said Dr Thomas E Lavin, founder of The Surgical Specialists of Louisiana and an investigator in the trial. "Surgery for weight loss has been studied with positive results, but this will be one of the first major trials to prospectively compare the effectiveness of an endoscopic procedure against a sham procedure plus diet and exercise.

Physicians participating in the study will use USGI Medical's g-Cath EZ Suture Anchor Delivery Catheter to place tissue anchors across folds of tissue in strategically-located parts of the stomach to reduce its size and ability to stretch to accommodate a meal. The company claims that the g-Cath, which is used extensively for general, non-obesity indications, is the first endoscopic suturing technology proven to create a durable, healed fold in the stomach.

“Based on preliminary studies conducted in Europe, we believe that this new approach may help patients feel full sooner during meals, improving satiety and reducing hunger cravings so they can control their portions, consume fewer calories and lose weight," Lavin added.

The incisionless outpatient procedure has been performed on over 2,000 patients, mostly in Europe, where it is known as Primary Obesity Surgery Endolumenal (POSE) procedure. The procedure is performed entirely through the mouth without any incisions through the abdomen. Many patients have returned to work without any bandages or signs of surgery within two to three days.

"If the data are positive and consistent with smaller trials, it could mean that tens of thousands of patients may have an incredibly compelling option to consider if they've struggled to lose weight with diet and exercise, but aren't prepared to accept the risk of traditional bariatric surgery," said Lavin.

"The start of the ESSENTIAL Trial represents a significant milestone for USGI Medical and endoscopic approaches to weight loss," said John Cox, Chief Operating Officer of USGI Medical. "Our efforts to support this study underscore our excitement about the potential of our technology and our commitment to patient safety and outcomes. We look forward to working with many of the country's leading bariatric surgeons and advanced endoscopists, both at top academic medical institutions and well-respected private centers, to enroll patients in this study. Based on our experience to date, we believe our new incisionless approach to treating obesity may offer promise to patients who have struggled to lose weight through diet and exercise."

European POSE results

At the recent 18th World Congress of International Federation for the Surgery of obesity & Metabolic Disorders (IFSO) in Istanbul, investiagtors from Spain reported results of two studies showing the positive outcomes and physiological effects of the POSE procedure.

Dr Román Turró, from the GI Endoscopy Department at the Centro Medico Teknon, Barcelona, reported the results of his team's POSE experience from 137 consecutive procedures performed from February 2011 to July 2013.

The average age of patients included in the safety analysis was 42.8 years and the average BMI 36.9 at the time of the procedure. Females accounted for 74% of the patients.

The first 22 patients who had been followed for 12 months post-procedure at the time of the presentation achieved average excess weight loss of 62% and total body weight loss of 19%.

Initial safety data were favourable with no reported instances of hospitalisation with a surgical intervention following the POSE procedure. One patient developed an infection that was treated with antibiotics and two patients suffered intra-gastric bleeding, which was treated endoscopically.

Endoscopies on a subset of these patients also confirmed that the suture anchors remained in place in the stomach 12 months after the procedure.

Also at IFSO, Dr Silvia Delgado-Aros, a member of the Neuro-Enteric Translational Science (NETS) Research Group at the Institut Hospital del Mar d'Investigacions Mèdiques in Barcelona, presented physiologic findings showing that POSE led to weight loss, a sustained reduction in caloric intake, normalisation of blood sugar levels and improved feelings of fullness and satiety triggered by an improved gut peptide response to food. In this controlled study, patients followed for 15 months reported mean excess weight loss of 63.7%.

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