Actively Recruiting
RESET System Pivotal Trial (Rev F)
Led by Morphic Medical Inc. · Updated on 2024-07-18
264
Participants Needed
7
Research Sites
377 weeks
Total Duration
On this page
Sponsors
M
Morphic Medical Inc.
Lead Sponsor
B
Biostatistical Consulting, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
RESET System Pivotal Trial (Rev F)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years to 65 years
- Signed informed consent form
- Diagnosis of type 2 diabetes
- HbA1c between 7.5% and 10%
- BMI between 30 kg/m2 and 50 kg/m2
- Willing and able to follow study requirements
- Negative pregnancy test for women who can become pregnant
- Women of childbearing potential must use birth control and not intend pregnancy during the study
- At least one year of medical records including diabetes treatment history
- Failed to reach adequate HbA1c control (<7.5%) after at least 3 months of stable dual therapy diabetes medications including insulin, metformin, or other specified drugs
You will not qualify if you...
- Prior treatment with the RESET System
- Previous gastrointestinal surgery or abnormal GI anatomy affecting RESET Liner placement or function
- Severe hypoglycemia or diabetic ketoacidosis in last 6 months needing assistance
- Known liver disease or severe fibrosis/cirrhosis
- Kidney function (eGFR) below 45 ml/min/1.73 m2
- History of abscess requiring hospitalization or drainage
- Prior severe liver or biliary tract disease treatments
- Diagnosis of type 1 diabetes or history of ketoacidosis
- Low fasting C-peptide (<1.0 ng/mL)
- High triglycerides (>600 mg/dL)
- Vitamin D deficiency (<20 ng/ml)
- Bleeding disorders or low platelets
- Height under 5 feet (152.4 cm)
- Current addiction to alcohol or drugs
- History of pancreatitis or gallstone-related pancreatitis
- Bone disorders such as osteopenia or osteoporosis or current use of related medications
- Autoimmune connective tissue diseases
- Recent or active severe gastroesophageal reflux disease unless treated with specific medications
- Uncontrolled thyroid disease or history of thyroid cancer
- Use of antithrombotic therapy near study start or expected need during study
- Use of restricted medications or supplements affecting study outcomes
- Active H. pylori infection
- History of Crohn's disease or untreated intestinal stenoses
- Recent gastrointestinal ulcers or bleeding
- Any condition posing undue risk per investigator
- Poor dental health affecting chewing
- Recent participation in other investigational studies
- Lack of access to study medical resources
- Recent significant weight loss
- Positive fecal immunochemical test at screening
- Psychological disorders affecting compliance
- No active telephone or internet access for follow-up
- Recent blood donation or transfusion
- Conditions causing increased red cell turnover
- Presence of specific bacterial infections
- Sensitivity to nickel or titanium
- MRI unsuitability
- History or suspicion of coronary artery disease
AI-Screening
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Trial Site Locations
Total: 7 locations
1
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
University of Miami Hospital
Miami, Florida, United States, 33166
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Michigan Medicine, Division of Gastroenterology and Hepatology
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
6
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
7
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Stephen J Linhares, BS
CONTACT
A
Aoife Devery, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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