No phaseRecruiting
The RESET System Pivotal Clinical Trial (Protocol Revision K) (STEP-1)
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. (Industry)
- Enrolment
- 264 planned
- Conditions
- Diabetes type2; Obesity
- Interventions
- RESET Liner; Sham
- Ages
- adults, older adults
- Registry
- NCT04101669
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Change in HbA1c
- SAE Rate
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started