The purpose of this study is to evaluate the safety and effectiveness of an experimental device called the ReCET Intestinal Cellular Regeneration System for improving glycemic (blood sugar) control in individuals with type 2 diabetes (T2D). The ReCET device is designed to treat the lining of the first part of the small intestine (duodenum) in order to improve blood sugar control in individuals with T2D. The procedure is done through the mouth using a small camera (endoscopic procedure). Previous research shows that the cells in the small intestine lining play a role in controlling blood sugar levels. In people with T2D, these cells may not be working properly. Treatment that helps new growth of these cells has shown promise in helping the body better manage blood sugar levels. The ReCET device uses a catheter to deliver pulsed electric field to the lining of the duodenum. The pulsed electric field causes the cells in the lining to die, replacing them with the growth of new cells. Participants will be randomly assigned to 1 of 2 groups. One group will receive the ReCET therapy, and the other group will receive the same endoscopic procedure but without the actual energy applications. There is a 2 to 1 chance that any participant will be assigned to the ReCET therapy group. Both groups will receive the same medical care, monitoring, and lifestyle coaching. If assigned to the group that did not receive the ReCET procedure, the participant will be given the choice to have the procedure and then be enrolled in the study registry.
What is the full name of this clinical trial?
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