MedTrace Logo

Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes

NCT06267391 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Endogenex, Inc.

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-04-01
Completion
2026-10-01
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267391 on ClinicalTrials.gov