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TransPyloric Shuttle demonstrates weight loss
The results from ENDObesity study, which is assessing the safety and efficacy of the experimental TransPyloric Shuttle (TPS, BAROnova Inc.) device, has concluded that the device is safe, well-tolerated and resulted in statistically significant improvements in weight-related quality of life (QoL) measures. The research was presented at the 30th Annual Meeting for the American Society for Metabolic and Bariatric Surgery (ASMBS) during ObesityWeek 2013, the largest international event focused on the basic science, clinical application and prevention and treatment of obesity. The event was hosted by the ASMBS and The Obesity Society (TOS).
TransPyloric Shuttle is a non-surgical device that is delivered endoscopically to the stomach to treat chronic obesity. The TPS is deployed into the stomach to mechanically form a large spherical bulb connected to a smaller cylindrical bulb by a flexible tether. The larger bulb prevents migration from the stomach, while the smaller bulb passes freely into the duodenum during peristalsis to enable self-positioning of the TPS across the pylorus.
Once transpyloric, the larger bulb engages the pylorus directly to form an intermittent seal designed to delay gastric emptying, enhance satiety, and enable a reduction in caloric intake.
ENDObesity is a prospective, open-label, non-randomised single-centre study in Sydney, Australia, in which patients were serially assigned to three-month and six-month treatment cohorts. Change in excess weight and improvements in weight specific quality of life were evaluated. In particular, the researchers assessed the effect of the device on an individual in five domains: physical function, self-esteem, sexual life, public distress, work and overall.
The results revealed that delivery and removal of the TPS device were successfully performed in outpatient endoscopic settings using a standard gastric overtube for access and oesophageal protection. Deployment and retrieval times for the device were typically less than 15 minutes (10.3+/-3.9 and 12.9+/- 6.4) respectively.
The devices were removed one t- two weeks prior to completion of the planned treatment period in two subjects due to the development of symptomatic gastric ulcerations. Baseline mean BMI across the twenty subjects was 36.0 -/±5.4. At device removal in the three and six-month cohorts, mean BMI reductions were 3.1±1.7 and 5.6± 2.1, respectively. This equated to a percent EWL of 31.3%±15.7% at three months and 50.0%±26.4% at six months.
With regards to QoL score, three- and six-month patients mean scores improved by:
- 17.4±15.7 and 26.3±26.0 for physical function
- 32.9±23.7 and 34.8±25.5 for self-esteem
- 21.8±24.4 and 29.1±26.6 for sexual life
- 11.3±21.0 and 8.9±19.8 for public distress
- 16.3±18.4 and 6.8±15.3 for work and
- 20.4±14.2 and 23.2Â±20.5 overall.
“The present study demonstrated substantial weight loss in 20 subjects using an experimental, non-surgical device therapy,” said Dr George Marinos, primary investigator in the ENDObesity I clinical study and a gastroenterologist at the Gastric Balloon & Lapband Australia clinic and the Prince of Wales Hospital, as well as a senior lecturer at the University of New South Wales. “Treatment with the TPS was safe, well-tolerated and resulted in meaningful improvements in weight-related QoL measures that reached statistical significance, p<0.05, in physical function, self-esteem, sexual life, and overall domains after three and six-month periods.”
To access the posters and abstracts from Obesity Week, please click here