A Totally Endoscopic Device for the Treatment of Morbid Obesity

Introduction: Morbid obesity is a major health concern for the United States affecting over 15 million people. Despite its associated comorbidities, less than 1% of patients seek surgical intervention. The need for less costly, minimally invasive procedures that reduce complication rates and result in faster recovery would be a valuable adjunct in the treatment of morbid obesity.
Methods: The EndoBarrierTM (GI Dynamics, Inc) duodenal-jejunal bypass sleeve is a totally endoscopic delivered device designed to produce weight loss by altering metabolic pathways. It is comprised of a self-expanding nitinol anchor, an impermeable, fluoropolymer sleeve, and two retrieval drawstrings. The coaxial, catheter-based delivery system is introduced into the duodenal bulb over a guide wire and deployed utilizing fluoroscopy. Proximally placed barbs penetrate into the muscularis propria and allow for anchor stabilization within the duodenal bulb. Upon deployment, a bolus of dilute contrast confirms correct device positioning. A duodenal-jejunal bypass is created as chyme passes through the inside of the impermeable EndobarrierTM, while bile and pancreatic enzymes pass outside the sleeve and mix with the chyme at its distal end. An institutional-IRB approved, randomized, single-blind, placebo-controlled, FDA trial evaluating the deployment, efficacy, and removal of the EndoBarrier TM is underway.
Results: Patients have been consented to either receive the Endobarrier TM device or undergo a sham procedure. The device will be removed after 90 days. The first patient was a 36 year-old female (BMI 45.2, 263lbs). Post-procedure, she has lost 9.2 and 16 pounds at 4 and 12 weeks respectively. Two other patients have lost 12.8, and 8.4 pounds at 4 weeks. Two controls have lost 4.4 and 13.8 pounds and one control gained 0.8 pounds at 4 weeks.
Conclusions: We describe the first placement of a duodenal-jejunal bypass sleeve in the United States. The Endobarrier TM may offer the morbidly obese population a new method of weight loss that requires no surgical intervention, minimizes cost and improves post-procedure recovery. Our current study aims to demonstrate safety and help elucidate the mechanisms of weight loss to better understand the future clinical applications of this novel technique.

Session: Podium Video Presentation

Program Number: V056

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