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RESET System Pivotal Trial (Rev F)
NCT04101669 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Morphic Medical, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04101669 reports 7 study locations spanning 7 distinct geographic areas — top geographies include District of Columbia, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04101669?
The interventions under investigation include: RESET Liner (DEVICE), Sham (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04101669?
This trial is sponsored by Morphic Medical, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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