Trials / Completed
CompletedNCT05014204
Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes
Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Endogenex, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Individuals who sign the informed consent will be screened for study eligibility. Eligible participants will be treated with the Endogenex procedure and followed up for 48 weeks.
Conditions
- Diabetes
- Diabetes Type 2
- Diabetes Mellitus, Type 2
- Glucose Metabolism Disorders
- Metabolic Disease
- Endocrine System Diseases
- Diabetes Mellitus
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-10-29
- Primary completion
- 2024-05-29
- Completion
- 2025-05-29
- First posted
- 2021-08-20
- Last updated
- 2025-12-22
- Results posted
- 2025-12-22
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05014204. Inclusion in this directory is not an endorsement.