Last reviewed · How we verify
Endoscopic Application of Pulsed Electric Fields Using by the Endogenex Generation 2 ReCET System for Duodenal Mucosal Regeneration for EliMination of INsulin in the treatmENT of Type 2 Diabetes: a Randomized Double-blind Sham Controlled Trial to Evaluate Safety, Feasibility and Efficacy Study (EMINENT-2)
The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (ReCET system by the Endogenex with the Gen-2 catheter) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus.
Details
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
|---|---|
| Phase | NA |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 32 |
| Start date | 2023-08-03 |
| Completion | 2026-07 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- ReCET
- Semaglutide, 1.0 mg/mL
- Sham procedure
Primary outcomes
- Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety] — 24 weeks
The incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs 24 weeks post ReCET procedure. - Percentage of patients off insulin at 24 weeks [efficacy] — 24 weeks
Percentage of patients free of insulin at 24 weeks post ReCET with an HbA1c ≤ 58 mmol/mol compared to sham.
Countries
Netherlands