Study S000896

Endoscopic Application of Pulsed Electric Fields Using the Endogenex Generation 2 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

ClinicalTrials.gov record

Registration

Registration: NCT05984238
Acronym: EMINENT-2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 33
Start: 2023-08-03
Primary completion: 2025-03-21
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions: Diabetes Mellitus, Type 2
Interventions: DEVICE:PEF therapy using the Endogenex Device; DRUG:Semaglutide, 1.0 mg/mL; OTHER:Sham procedure
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety] [24 weeks]
Percentage of patients off insulin at 24 weeks [efficacy] [24 weeks]

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