Salman Alsabah, Shehab Ekrouf, Waleed Bohaimed, Ahmed Al-Mulla, Saud Al-Subaie, Mubarak Al-Kandiri. Al- Amiri Hospital Kuwait
Objectives: The objective of this study was to evaluate the safety and performance of Elipse™, a procedureless gastric balloon for weight loss.
Description of the technology and method of its use or application: The Elipse™ balloon is rolled into a capsule and swallowed along with a thin delivery catheter for filling fluid. It is flexible enough to fold into capsule and pass through the gastrointestinal tract. After delivery of the fluid, it seals shut and the delivery catheter is pulled out. It is durable enough to spend months in stomach. The release valve built into the balloon weakens over time, and then opens catastrophically, allowing the balloon to empty and pass naturally.
Each patient swallowed one Elipse™ balloon intended to remain in the stomach for 4 months, self-empty, and then pass. Each balloon was filled with 550 mL of filling fluid.
Preliminary results: Ninety-three patients with mean BMI pre-insertion = 33.9± 3.6 participated in this study age, 34.2 ± 9.9 years; 75 females [80.6 %]. All patients were able to tolerate swallowing the balloon either naturally or with the aid of stylet (n=29). 4 patients could not tolerate the balloon with early endoscopic removal within the first week. 3 patients had early deflation. At 2 months mean weight loss is 7.4±4.9 kgs with a mean BMI of 31±3.7 (n=71) At 4 months the mean weight loss is 14.6±4.8 kgs with a BMI of 28.3±3.6 (n=55). The most common adverse events were nausea and vomiting. There were no serious adverse events, and all balloons were excreted safely except for 3 patients who vomited the balloon at time of excretion.
Conclusions / future directions: The Elipse™ balloon is feasible, safe, and effective in the short term. Since it does not require endoscopy or sedation, Elipse™ can potentially be used by physicians in an office setting and poses less invasiveness, risk, and cost to the patient. A multidisciplinary team is needed and more research is needed with larger studies and longer follow-up.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 84299
Program Number: ET002
Presentation Session: Emerging Technology Session
Presentation Type: Podium