Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
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 (ReCET Study)
Endogenex, Inc.
264 participants
May 1, 2024
INTERVENTIONAL
Conditions
Summary
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Treatment arm will receive the ReCET therapy. The ReCET procedure utilizes the ReCET catheter to deliver non-thermal pulsed electric field to the first portion of the small intestine (duodenum) to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum. Participants will be followed for 12 months post procedure.
The Control arm will receive a sham procedure. The sham procedure consists of placing the ReCET catheter as described above without therapy applied. Participants will be followed for 12 months post procedure and will be offered cross-over to receive the ReCET therapy after 12 months.
Locations(45)
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NCT06267391