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

NCT05984238 · Active, not recruiting

Last updated 2026-05-28

This trial tests the safety and feasibility of the ReCET procedure in adults with type 2 diabetes.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 32 people Planned (estimated).

Who can join Ages 28–75 · all sexes

Timeline Started 2023-08 · est. completion 2026-07

Where 1 site · Netherlands

What this study is testing ClinicalTrials.gov NCT05984238 ↗

Description as written by the study sponsor.

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.

Treatments tested

ReCET Device

Investigational product.
Semaglutide, 1.0 mg/mL Drug

Already registered medicine for type 2 diabetes
Sham procedure Other

The sham control for the ReCET procedure.

Main thing measured	Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety]
Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05984238 ↗