264
Participants
Start Date
May 1, 2024
Primary Completion Date
April 1, 2026
Study Completion Date
October 1, 2026
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.
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.
RECRUITING
Royal Prince Alfred Hospital, Camperdown
RECRUITING
The BMI Clinic, Double Bay
RECRUITING
Royal North Shore Hospital, Saint Leonards
RECRUITING
Baker Heart and Diabetes Institute, Melbourne
RECRUITING
St Vincent's Hospital Melbourne, Fitzroy
RECRUITING
Eastern Health - Box Hill Hospital, Box Hill
RECRUITING
John Hopkins, Baltimore
RECRUITING
Mayo Clinic, Jacksonville
RECRUITING
Advent Health, Orlando
RECRUITING
Orlando Health, Orlando
RECRUITING
Velocity Clinical Research, Hallandale Beach, Hallandale
RECRUITING
Quantum Clinical Research, Miami Beach
RECRUITING
Universal Axon Clinical Research LLC, Miami
RECRUITING
University of Miami, Miami
RECRUITING
Health Synergy Clinical Research, West Palm Beach
RECRUITING
West Orange Endocrinology, Ocoee
RECRUITING
University of Alabama, Birmingham
RECRUITING
Central Alabama Research, Birmingham
RECRUITING
The Ohio State University- Wexner Medical Center, Columbus
RECRUITING
Iowa Diabetes and Endocrinology Research Center, West Des Moines
RECRUITING
Heartland Medical Research, Inc., Clive
RECRUITING
Mayo Clinic, Rochester
RECRUITING
NorthShore University Health System, Evanston
RECRUITING
Epic Medical Research, DeSoto
RECRUITING
Velocity Clinical Research, Dallas, Dallas
RECRUITING
Southwest Medical Center, Dallas
RECRUITING
University of Texas Southwestern Medical School - William P. Clements Jr. University Hospital, Dallas
RECRUITING
Houston Methodist Research Institute, Houston
RECRUITING
Juno Research, LLC, Houston
RECRUITING
The University of Texas Health Science Center at Houston, Bellaire
RECRUITING
Mt. Olympus Medical Research, Sugar Land
RECRUITING
Diabetes & Glandular Disease Clinic, P.A., San Antonio
RECRUITING
IMA Clinical Research - San Antonio, San Antonio
RECRUITING
Velocity Clinical Research - Austin, Austin
RECRUITING
Texas Diabetes & Endocrinology, P.A., Round Rock
RECRUITING
Dell Medical School, Austin
RECRUITING
IMA Clinical Research - Austin, Austin
RECRUITING
Cedars-Sinai Medical Center, Los Angeles
RECRUITING
UCLA, Los Angeles
RECRUITING
Velocity Clinical Research, Gardena, Gardena
WITHDRAWN
Velocity Clinical Research, Panorama City, Panorama City
RECRUITING
Hoag Memorial Hospital Presbyterian - Digestive Health Institute, Newport Beach
RECRUITING
Cooper Health System, Camden
RECRUITING
Robert Wood Johnson Medical School, New Brunswick
RECRUITING
Austin Health, Heidelberg
Lead Sponsor
Endogenex, Inc.
INDUSTRY