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Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes

NCT05014204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-22

Study results available
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Summary

This is a multi-center, open-label study to assess the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes inadequately controlled on 2-3 non-insulin glucose-lowering medications.

Conditions

  • Diabetes
  • Diabetes Type 2
  • Diabetes Mellitus, Type 2
  • Glucose Metabolism Disorders
  • Metabolic Disease
  • Endocrine System Diseases
  • Diabetes Mellitus

Interventions

DEVICE

The Endogenex Device

The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field. The Endogenex procedure is a non-surgical, endoscopic procedure.

Sponsors & Collaborators

  • Endogenex, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel DeMarco, MD · Baylor Scott & White

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2024-05-29
Completion
2025-05-29
FDA Device
Yes

Countries

  • United States

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 NCT05014204 on ClinicalTrials.gov