Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT06073457
Brief Summary:
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults.
Detailed Description:
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults. This partial diversion of intestinal contents from the stomach to the ileum or jejunum is intended to facilitate weight management/loss in obese adults and improve metabolic outcomes in obese adults with type 2 diabetes mellitus ("T2DM"). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single anastomosis sleeve ileal (SASI) bypass procedure that includes a gastro-ileostomy at the distal antrum of the stomach. Additionally, the one anastomosis gastric bypass (OAGB) or single anastomosis gastric bypass (SAGB) performed in two stages may also be considered a predicate procedure where an anastomosis between the jejunum and anterior lesser curvature of the stomach is performed, followed by a second stage gastric pouch stapling more than 12 months later (non-study procedure).
Study:
NCT06073457
Study Brief:
Protocol Section:
NCT06073457