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

Summary

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.

Timeline

Start

2023-08-03

Primary completion

2025-03-21

Completion

2026-05-28

Publications

• Busch CBE, van den Hoek K, Neefjes-Borst EA, Nieuwdorp M, van Baar ACG, Bergman JJHGM. Optimizing duodenal tissue acquisition for mechanistic studies of duodenal ablation in type 2 diabetes. Endosc Int Open. 2025 Jan 29;13:a25032135. doi: 10.1055/a-2503-2135. eCollection 2025.
• Musso G, Pinach S, Saba F, De Michieli F, Cassader M, Gambino R. Endoscopic duodenal mucosa ablation techniques for diabetes and nonalcoholic fatty liver disease: A systematic review. Med. 2024 Jul 12;5(7):735-758.e2. doi: 10.1016/j.medj.2024.03.014. Epub 2024 Apr 4.

Drugs

Indications