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NCT04101669 · ClinicalTrials.gov registry record · NA
RESET System Pivotal Trial (Rev F)
A NA study of Obesity and Diabetes Type 2, sponsored by Morphic Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 264
- Enrollment target
- 7
- Study locations
NCT04101669: Recruiting NA study of Obesity and Diabetes Type 2, sponsored by Morphic Medical.
NCT04101669 is a NA study of Obesity and Diabetes Type 2 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04101669, a NA study of Obesity and Diabetes Type 2, 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).
Primary Outcome
Change in HbA1c value from baseline to 9 months.
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 |
What NCT04101669 shows while recruiting
NCT04101669 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (68% lower).
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 lists 7 locations in 7 states (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 Type 2.
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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04101669's enrollment target sits among peer trials
264 246th of 1053 higher than 807 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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