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NCT04101669 · ClinicalTrials.gov registry record · NA
RESET System Pivotal Trial (Rev F)
A NA study of Obesity and Diabetes type2, sponsored by Morphic Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 264
- Enrollment target
- 7
- Study locations
NCT04101669 is a NA study of Obesity and Diabetes type2 that is actively recruiting participants, run by Morphic Medical. The registered enrollment target is 264 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (68% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT04101669, a NA study of Obesity and Diabetes type2, is actively recruiting participants, sponsored by Morphic Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 264 participants
- Enrollment target
- 7
- Study locations
Study 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).
Conditions Studied
Interventions
- DEVICE RESET Liner
- OTHER Sham
Study Locations (7)
District of Columbia
- MedStar Health Research Institute - Washington D.C.
Florida
- University of Miami Hospital - Miami
Massachusetts
- Brigham and Women's Hospital - Boston
Michigan
- Michigan Medicine, Division of Gastroenterology and Hepatology - Ann Arbor
New York
- Weill Cornell Medicine - New York
Ohio
- Cleveland Clinic - Cleveland
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2026-12-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04101669
The ClinicalTrials.gov registry entry for NCT04101669 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (68% lower). The listed sponsor is Morphic Medical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which RESET Liner is the first listed.
NCT04101669 reports 7 study locations spanning 7 distinct geographic areas - top geographies include District of Columbia, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04101669 about?
NCT04101669 is a clinical study titled "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, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and eff...
What is the current status of trial NCT04101669?
This trial is currently recruiting. It is a NA study. The enrollment target is 264 participants. The study started on 2019-09-09. Estimated completion is 2026-12-01.
What conditions does trial NCT04101669 study?
This clinical trial studies the following conditions: Obesity, Diabetes type2.
What interventions are being tested in trial NCT04101669?
The interventions under investigation include: RESET Liner (DEVICE), Sham (OTHER).
Who is sponsoring clinical trial NCT04101669?
This trial is sponsored by Morphic Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04101669 being conducted?
This trial has 7 study locations across District of Columbia, Florida, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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