A Novel Endoscopic Treatment for Resolving Type 2 Diabetes Mellitus

Yoav Mintz, MD¹, Santiago Horgan, MD², Pablo Omelanczuk, MD³, Steven Haas⁴, Izhak Fabian, MSC⁴. ¹Hadassah Medical Center, ²University of California San Diego, ³Hospital Italiano de Mendoza, ⁴EasyNOTES Medical

Objectives: The Roux-en-Y gastric bypass operation effectively induces weight loss and long-term control of type 2 diabetes mellitus (T2DM). Previous studies demonstrated that the duodenal jejunal exclusion by itself has a role in this process rather than the weight loss alone. We designed a novel endoscopic method to mimic the gastric bypass operation in order to resolve the T2DM without inducing significant weight loss. Our aim was to develop a simple procedure that can be achieved endoluminally with minimal patient risks.

Description of the technology : self-aligning neodymium rare earth magnets, enclosed in a biocompatible shell, were designed. A jejunal magnet is delivered and deployed into the proximal jejunum using an enteroscope. A gastric magnet is then delivered into the stomach and both magnets are joined together under fluoroscopy using a large external magnet. Following approximately 7 days these magnets create a gastro-jejunal compression anastomosis and are expelled. A second gastroscopy is then performed and a pyloric plug is inserted into the duodenum to block passage of food through the duodenum thereby creating a gastro-jejunal bypass. This pyloric plug is consisted of two inflatable balloons that effectively block food and liquids without injuring the intestine and could be removed if necessary.

Preliminary results: Large animal studies were performed and a system of deploying magnets and creating compression anastomosis was developed. Following successful anastomosis creation a pyloric plug was positioned successfully to create the bypass. A preliminary human study was performed to position the pyloric plug.

Conclusions: T2DM affect approximately 350 million people worldwide. Gastro-jejunal bypass can potentially cure this disease. A simple and low risk endoluminal procedure was successfully developed in large animal models. This procedure is reversible by means of removing the pyloric plug. Human trials are planned to assess the feasibility and safety of this system.