RESET System Pivotal Trial (Rev F)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorMorphic Medical Inc.
About this trial
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 criteria
Qualifiers
Age ≥22 years and ≤ 65 years
Have understood and signed the approved informed consent form
Diagnosis of type 2 diabetes
HbA1c ≥ 7.5% and ≤10%
Disqualifiers
Previous treatment with the RESET System
Previous GI surgery that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner, or abnormal GI anatomical finding that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner
Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance
Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2 or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but not including incidental fatty liver)
Trial design
Treatments tested in this trial
- RESET Liner
- Sham
Treatment groups
264 Participants
are divided into 2 treatment groupsSponsors and collaborators
Morphic Medical Inc.
Lead sponsor
Biostatistical Consulting, Inc.
Collaborator
Source ClinicalTrials.gov