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COMPLETED
NCT05984238
NA

A Trial to Evaluate Safety, Feasibility and Efficacy of Endoscopic Duodenal PEF Therapy

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (with the Endogenex System en Gen 2 Device) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus.

Official title: Endoscopic Application of Pulsed Electric Fields Using the Endogenex Generation 2 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

Key Details

Gender

All

Age Range

28 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2023-08-03

Completion Date

2026-05-28

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

DEVICE

PEF therapy using the Endogenex Device

Investigational product.

DRUG

Semaglutide, 1.0 mg/mL

Already registered medicine for type 2 diabetes

OTHER

Sham procedure

The sham control for the PEF therapy procedure.

Locations (1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands