Trials / Active Not Recruiting

Active Not RecruitingNCT05984238

A Trial to Evaluate Safety, Feasibility and Efficacy of the ReCET Procedure (EMINENT-2)

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

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 32 (estimated)

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
Sex: All
Age: 28 Years – 75 Years
Healthy volunteers: Not accepted

Summary

Detailed description

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 and an adequate beta cell reserve in a randomized sham-controlled study. The aimed effect is an adequate or improved glucose regulation without the need for insulin therapy. Secondary effects include improved cardiovascular, hepatic, and metabolic parameters.

Conditions

Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	ReCET	Investigational product.
DRUG	Semaglutide, 1.0 mg/mL	Already registered medicine for type 2 diabetes
OTHER	Sham procedure	The sham control for the ReCET procedure.

Timeline

Start date: 2023-08-03
Primary completion: 2025-03-21
Completion: 2026-07-01
First posted: 2023-08-09
Last updated: 2026-01-15

Locations

1 site across 1 country: Netherlands

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT05984238. Inclusion in this directory is not an endorsement.