Continued Access to the Endogenex System for Participants in the ReCET Pivotal Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Endogenex, Inc.
Study ID
NCT07197788
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endogenex System — DEVICE
    The Endogenex System procedure utilizes a 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.

Study Details

This study is designed to collect real-world data on the safety and performance of the Endogenex System in the cohort of participants who were originally randomized to the sham control arm of the ReCET Study.

Key Dates

Start date
Jul 31, 2026
Status verified
Dec 2025
Primary completion
Oct 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Endogenex System Treatment
    Treatment arm will receive the Endogenex System procedure.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: 6 months post-procedure ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35205-
HCA Florida Mercy HospitalMiamiFlorida33133-
Orlando HealthOrlandoFlorida32806-
NorthShore University Health SystemEvanstonIllinois60201-
Care AccessQuincyMassachusetts02169-
Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-
Care AccessRaleighNorth Carolina27607-
The University of Texas Health Science Center at HoustonBellaireTexas77401-
University of Texas Southwestern Medical School - William P. Clements Jr. University HospitalDallasTexas75235-
Care AccessHoustonTexas77054-

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University of Alabama· Birmingham, ALHCA Florida Mercy Hospital· Miami, FLOrlando Health· Orlando, FLNorthShore University Health System· Evanston, ILCare Access· Quincy, MARobert Wood Johnson Medical School· New Brunswick, NJ

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