A Multicenter, Randomized, Double-blind, Sham-controlled study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals with Type II Diabetes

Investigator: Abhishek Kansara, MD

Study Coordinator: Michelle Nguyen

Status: Open Not Enrolling

ClinicalTrials.gov Number: NCT06267391

Phone: 346.238.4586

Protocol Number: PRO00038057

Description

This research study is designed to evaluate the safety and effectiveness of the ReCET™ device for improving glycemic (blood sugar) control in individuals with T2D. This study plans to enroll a minimum of 264 and a maximum of 350 participants from up to 40 centers in the US and Australia. The ReCET device is designed to treat the lining (called mucosa) of the first part of the small intestine (called the duodenum) for improving blood sugar control in individuals with T2D. The procedure is done through the mouth using a small camera (called endoscopic procedure).
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