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

NCT05984238 | Active Not Recruiting DMC FDA Device

• 1 other identifier: NL83266.000.22
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes; Duodenal ablation; Endoscopy; Electroporation

Outcome Measures

Primary Outcomes (2)

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

  The incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs 24 weeks post ReCET procedure.

  24 weeks

• Percentage of patients off insulin at 24 weeks [efficacy]

  Percentage of patients free of insulin at 24 weeks post ReCET with an HbA1c ≤ 58 mmol/mol compared to sham.

  24 weeks

Secondary Outcomes (5)

• Secondary safety endpoint 1 - hypoglycemic events

  Through study completion (1 to 1,5 year)

• Secondary safety endpoint 2 - SAEs

  Through study completion (1 to 1,5 year)

• Secondary feasibility endpoint 1 - technical success rate

  24 weeks (after cross-over)

• Secondary feasibility endpoint 2 - GLP-1RA tolerability

  Through study completion (1 to 1,5 year)

• Secondary efficay endpoint 1 - HbA1c 48 weeks

  at 48 weeks

Study Arms (2)

ReCET procedure

ACTIVE COMPARATOR

Patients receive ReCET (Re-Cellularization via Electroporation Therapy), which is performed using the ReCET device. After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started.

Device: ReCET; Drug: Semaglutide, 1.0 mg/mL

Sham procedure

SHAM COMPARATOR

Patients receive sham procedure, this consists of placing an Endogenex catheter, or a catheter with a similar circumference at the endoscopists discretion in the stomach and leaving it in place for 30 minutes. After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started

Drug: Semaglutide, 1.0 mg/mL; Other: Sham procedure

Interventions

ReCET DEVICE

Investigational product.

ReCET procedure

Semaglutide, 1.0 mg/mL DRUG

Already registered medicine for type 2 diabetes

ReCET procedure; Sham procedure

Sham procedure OTHER

The sham control for the ReCET procedure.

Sham procedure

Eligibility Criteria

• Age: 28 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes mellitus
• 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

You may not qualify if:

• Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
• Current use of multiple daily doses insulin or insulin pump.
• Current or within the last 3 months use of a GLP-1 analogue.
• 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
• 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
• History of chronic or acute pancreatitis
• Known active hepatitis or active liver disease
• Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
• History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
• 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
• Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 5 days before and 48 hours after the procedure in accordance with the local protocol. Use of aspirin is allowed.
• Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
• Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
• Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
• Anemia, defined as Hgb \< 6.2 mmol/l

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Endogenex: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40007651 DERIVED

Related Links

• Website for people that are interested in participating.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jacques JG Bergman, MD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, both the study team and the study subjects are blinded to the treatment through the 24 week follow-up visit. While the endoscopist is not blinded to individual treatments, he or she is blinded to cohort level data and is not responsible for patient follow-up. At the 24 week visit, the subject and study team are unblinded. The subjects who received the sham treatment undergo ReCET.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Model Details: This study is a single-center, double-blind, sham-controlled trial.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 9, 2023
• Study Start: August 3, 2023
• Primary Completion: March 21, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)