RecruitingNot ApplicableNCT04101669

RESET System Pivotal Trial (Rev F)

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET® System for Glycemic Improvement in Patients With Inadequately Controlled Type 2 Diabetes and Obesity


Sponsor

Morphic Medical Inc.

Enrollment

264 participants

Start Date

Sep 9, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET 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 RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 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 (RESET):1 (Sham).


Eligibility

Min Age: 22 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests the RESET System — a device placed temporarily inside the duodenum (the first part of the small intestine) that acts as a liner, mimicking some effects of metabolic surgery — for people with type 2 diabetes that is not well controlled on medications. The goal is to improve blood sugar control without major surgery. **You may be eligible if...** - You are between 22 and 65 years old - You have type 2 diabetes with an HbA1c (blood sugar control measure) between 7.5% and 10% - Your BMI is between 30 and 50 - You have tried at least two diabetes medications for 3 months without achieving good blood sugar control - You are not pregnant and agree to use contraception during the trial **You may NOT be eligible if...** - You have type 1 diabetes or a history of ketoacidosis - You have serious liver, kidney, or gastrointestinal disease - You have had previous stomach or intestinal surgery that might interfere with the device - You have a history of pancreatitis, H. pylori infection, or Crohn's disease - You are taking blood thinners, proton pump inhibitors, or NSAIDs (like ibuprofen) - You have a history of coronary artery disease - You are allergic to nickel or titanium Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERESET Liner

The RESET System is provided as a single-use, sterile device and consists of an RESET Liner preloaded, packaged and sterilized within the RESET Delivery System. The RESET Delivery System is utilized to deliver the RESET Liner to the proximal small intestine. The RESET Liner is removed using the RESET Retrieval System. The RESET System incorporates no pharmacological, biological tissue or blood products.

OTHERSham

Patient receives upper endoscopy but no treatment


Locations(7)

MedStar Health Research Institute

Washington D.C., District of Columbia, United States

University of Miami Hospital

Miami, Florida, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Michigan Medicine, Division of Gastroenterology and Hepatology

Ann Arbor, Michigan, United States

Weill Cornell Medicine

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Baylor College of Medicine

Houston, Texas, United States

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NCT04101669


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