CompletedNot Applicable

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

Netherlands33 participantsStarted 2023-08-03

Plain-language 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.

Who can participate

Age range

28 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosed with type 2 diabetes mellitus
. 28 - 75 years of age
. On daily long acting insulin dose ≤ 1 U/kg, with a stable dose (within 10%) over 1 month
. BMI ≥ 24 and ≤ 42 kg/m2
. HbA1c ≤ 64 mmol/mol (8.0%)
. Fasting C-peptide ≥ 0.2 nmol/L (0.6 ng/ml)
. Willing to comply with study requirements and able to understand and comply with signed informed consent

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety]

Timeframe: 24 weeks

Percentage of patients off insulin at 24 weeks [efficacy]

Timeframe: 24 weeks

Trial details

NCT IDNCT05984238

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-21

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials