NCT06267391

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Endogenex, Inc. · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center, randomized, double-blind, sham-controlled, adaptive study enrolling individuals with type 2 diabetes inadequately controlled on non-insulin glucose-lowering medications. Participants will be randomized to receive the ReCET therapy or sham procedure consisting of device insertion without treatment. Participants will be followed for 6 months for the primary endpoint and 12 months in total. After 12 months, participants randomized to the sham arm may cross-over to receive the ReCET procedure.

Conditions

• Type 2 Diabetes Mellitus
• Type2diabetes
• Diabetes Mellitus, Type 2
• Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	ReCET Treatment	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.
DEVICE	Sham 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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2024-02-20
• Last updated: 2025-08-12

Locations

45 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study