Evaluating the Safety and Effectiveness of the Gastric Bypass Stent System for Treating Liver Fibrosis in Obese Adults in Europe

What this Trial Is About

Researchers are evaluating the Gastric Bypass Stent System as a potential non-invasive treatment for hepatic fibrosis in obese patients. This pilot, prospective, single-arm clinical investigation aims to assess the safety and performance of this device in Europe. The study is sponsored by MDCECRO LLC and focuses on patients with suspected or confirmed NASH fibrosis who have not achieved sufficient weight loss through lifestyle modifications or non-invasive treatments. The study involves implanting the Gastric Bypass Stent System under gastroscopy during a procedural period following a screening phase. Ten subjects will be enrolled from two sites in Latvia, and participants will be followed through a post-procedure follow-up period. This clinical investigation will monitor various health markers and outcomes to evaluate the devices impact. Participants will undergo assessments including liver biopsies, Fibroscan, blood tests for liver function, glucose, and lipid markers, as well as measures of weight loss and liver stiffness over 12 months. The primary outcome is the change in Nonalcoholic Steatohepatitis Clinical Research Network NASH CRN score at six months post-implantation. Safety, performance, and multiple laboratory and imaging markers will be tracked throughout the study period, which lasts up to one year after the procedure.

The Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region