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

NCT07197788 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Endogenex System

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.

Sponsors & Collaborators

  • Endogenex, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-10-31
Completion
2027-10-31
FDA Device
Yes

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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 NCT07197788 on ClinicalTrials.gov