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Found 2 Actively Recruiting clinical trials
Actively Recruiting
This research aims to evaluate the long-term weight loss outcomes of patients who underwent an Endoscopic Sleeve Gastroplasty (ESG) procedure at least five years before joining the study. The focus is on understanding the sustained weight loss journey and the effectiveness of ESG for managing obesity and related medical conditions over an extended period. Participants in this study have previously received the ESG procedure using the Overstitch Endoscopic Suturing System and have completed follow-up visits for weight loss management at one year and annually between two and four years after the procedure. The study involves no new interventions but includes retrospective data collection and one prospective visit at five or more years after the ESG procedure. During the study, participants will complete one prospective visit, during which researchers will assess the proportion of individuals who maintain clinically significant weight loss five years after the ESG procedure. The study includes reviewing follow-up data collected over several years to understand long-term weight loss maintenance. Participants must be able to read, understand, and sign consent forms to participate.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of a new endoscopic intestinal re-cellularization therapy called ReCET in people with type 2 diabetes who are not adequately controlled on non-insulin glucose-lowering medications. This multi-center, randomized, double-blind, sham-controlled study aims to compare the ReCET therapy with a sham procedure where the device is inserted but no treatment is applied. Participants will be followed for a total of 12 months, with the primary outcome measured by HbA1c levels 6 months after the procedure. After 12 months, those initially in the sham group may receive the ReCET therapy if they choose to cross over. The ReCET therapy involves using a catheter inserted through the mouth into the first part of the small intestine (duodenum) to deliver a non-thermal pulsed electric field that promotes cell regeneration. Participants will either receive this active treatment or a sham procedure involving only catheter placement without therapy. Both groups will be monitored closely for 12 months following their respective procedures. After one year, participants in the sham group have the option to receive the ReCET treatment. During the study, participants will undergo regular assessments including laboratory tests to monitor blood sugar control and safety. Researchers will track HbA1c levels, which indicate average blood glucose, at 6 months post-procedure to evaluate effectiveness. Participants must attend scheduled visits and comply with all study procedures, including safety monitoring, throughout the 12-month follow-up period. This careful monitoring helps ensure any changes in diabetes management or health status are recorded and evaluated.