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A Trial to Evaluate Safety, Feasibility and Efficacy of the ReCET Procedure (EMINENT-2) | Clinical Trials | Clareo Health

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

Endoscopic Application of Pulsed Electric Fields Using by the Endogenex Generation 2 ReCET 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

NCT05984238•Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

Detailed Description

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 and an adequate beta cell reserve in a randomized sham-controlled study. The aimed effect is an adequate or improved glucose regulation without the need for insulin therapy. Secondary effects include improved cardiovascular, hepatic, and metabolic parameters.

Eligibility

Age

28 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
•2. Current use of multiple daily doses insulin or insulin pump.
•3. Current or within the last 3 months use of a GLP-1 analogue.
•4. Known autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
•5. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
•6. History of chronic or acute pancreatitis
•7. Known active hepatitis or active liver disease
•8. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
•9. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
•10. Use of anticoagulation therapy (such as phenprocoumon and acenocoumarol) which cannot be discontinued for 3-5 days before and 48 hours after the procedure and novel oral anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannot be discontinued for 48 hours before and 48 hours after the procedure in accordance with the local protocol
+16 more criteria

Locations (1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Key Dates

Start Date

August 3, 2023

Primary Completion Date

March 21, 2025

Completion Date

July 1, 2026

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

Diabetes Mellitus, Type 2

Interventions

ReCET

DEVICE

Semaglutide, 1.0 mg/mL

DRUG

Sham procedure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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