Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Diabetes Patients
A Randomized Double-blind Sham-controlled Trial to Evaluate Efficacy+Safety of Revita Duodenal Mucosal Resurfacing (DMR) Treatment Paradigm+Retreatment in Patients With Type 2 Diabetes Using Non-insulin Glucose Lowering Medications (REMIND)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
18 participants
Aug 9, 2024
INTERVENTIONAL
Conditions
Summary
The objective of this study is to evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham) and to evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared to baseline and a single DMR procedure) in patients with type 2 diabetes with non-insulin glucose lowering medications.
Eligibility
Plain Language Summary
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Interventions
The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa. For this study Revita® DMR procedure will be conducted as follows: DMR Treatment Paradigm 1- After initial 2 Lift and Ablate step, remaining Lift: Ablate steps will be conducted in 1:1 manner.
The sham control for the Revita DMR procedure.
Locations(1)
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NCT06092476