13845STEP-1OpenA Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the EndoBarrier® System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the EndoBarrier System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study.
A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the EndoBarrier System plus moderate intensity lifestyle and dietary counseling compliant with 2019 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (EndoBarrier):1 (Sham).20183128NCT04101669IndustrialAdultTreatmentDevice: EndoBarrier Liner
Other: ShamN/AOtherDiabetes type2
ObesityBrebbia, JohnMedstar Montgomery Medical Center; Medstar Washington Hospital CenterMedStar Medical & Surgical Research Network2026.1.0 Build 16 <a href="https://advarra.com" target="_blank">© 2026 Advarra, Inc.</a>