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

NCT05984238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-08-06

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

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.

Sponsors & Collaborators

  • Endogenex

    collaborator UNKNOWN

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Jacques JG Bergman, MD · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
28 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-03
Primary Completion
2025-03-21
Completion
2026-05-28
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05984238 on ClinicalTrials.gov