The RESET System Pivotal Clinical Trial (Protocol Revision K)
Public ClinicalTrials.gov record NCT04101669. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04101669
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 264 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 9, 2019 (Actual)
- Primary completion
- Dec 30, 2027 (Estimated)
- Completion
- Sep 30, 2029 (Estimated)
- Last update posted
- Oct 13, 2026
2019 – 2029
United States locations
- U.S. sites
- 27
- U.S. states
- 10
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Health | Gilbert | Arizona | 85234 | Recruiting |
| M3 Wake Research | Tucson | Arizona | 85710 | Recruiting |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Imagine Research | Boynton Beach | Florida | 33435 | Recruiting |
| HCA Health Research Institute | Miami | Florida | 33140 | Recruiting |
| UMiami | Miami | Florida | 33143 | Recruiting |
| Quantum Clinical Trials | Miami Beach | Florida | 33140 | Recruiting |
| Optimal Research Sites | Orange City | Florida | 32763 | Recruiting |
| Orlando Health | Orlando | Florida | 32806 | Recruiting |
| Denali Health Plant City | Plant City | Florida | 33563 | Recruiting |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | Recruiting |
| Health Synergy Clinical Research | West Palm Beach | Florida | 33407 | Not yet recruiting |
| Denali Health Atlanta | Atlanta | Georgia | 30083 | Recruiting |
| Drug Studies America | Marietta | Georgia | 30060 | Recruiting |
| EBGS Clinical Research | Snellville | Georgia | 30078 | Recruiting |
| Elevate Clinical Research, Lake Charles | Lake Charles | Louisiana | 70605 | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| Michigan Medicine, Division of Gastroenterology and Hepatology | Ann Arbor | Michigan | 48109 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| Weill Cornell Medicine | New York | New York | 10021 | Recruiting |
| Elevate Clinical Research, Atascocita | Atascocita | Texas | 77346 | Recruiting |
| M3 Wake Research | Dallas | Texas | 75224 | Recruiting |
| Epic Medical Research | DeSoto | Texas | 75115 | Recruiting |
| Care United Research | Forney | Texas | 75126 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| Elevate Clinical Research, Houston | Houston | Texas | 78504 | Recruiting |
| VAST Clinical Research | Prosper | Texas | 75078 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04101669, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04101669 live on ClinicalTrials.gov.