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A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing (DMR) Using the Revita® System in Subjects with Type 2 Diabetes on Insulin therapy

To assess the efficacy of Revita® DMR for improving HbA1c to <= 7% without the need of insulin in subjects with T2D compared to sham.To assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints.

A randomized double-blind sham-controlled trial to evaluate efficacy and safety of REvita® DMR Treatment ParadIgm 1 and RetreatmeNt in patients with type 2 Diabetes using non-insulin glucose lowering medications.

This study consists of the following objections:- To evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham)- To evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared…