NCT07197788

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

Endogenex Access Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Endogenex, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, open-label, treatment-only study designed to enroll individuals who participated in the ReCET Study, were randomized to the sham control arm, completed study follow-up, and are eligible, consented for participation in this study, and elect to receive treatment with the Endogenex System.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-09-29
• Last updated: 2025-09-29

Regulatory

• FDA-regulated device study