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

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT05984238
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
28 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ReCET — DEVICE
    Investigational product.
  • Semaglutide, 1.0 mg/mL — DRUG
    Already registered medicine for type 2 diabetes
  • Sham procedure — OTHER
    The sham control for the ReCET procedure.

Study Details

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.

Key Dates

Start date
Aug 3, 2023
Status verified
Jan 2026
Primary completion
Mar 21, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: ReCET procedure
    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.
  • Sham Comparator: Sham procedure
    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

Primary Outcome Measure

Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety] [ Time Frame: 24 weeks ]

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