Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes
Public ClinicalTrials.gov record NCT04419779. 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 Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center, Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes With Inadequate Glycemic Control
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.
Study identification
- NCT ID
- NCT04419779
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 320 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 21 Years to 70 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
- Mar 8, 2021 (Actual)
- Primary completion
- Jan 2026 (Estimated)
- Completion
- Jan 2026 (Estimated)
- Last update posted
- Nov 13, 2025
2021 – 2026
United States locations
- U.S. sites
- 51
- U.S. states
- 19
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Helios CR, Inc | Phoenix | Arizona | 85028 | — |
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | — |
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | — |
| Angel City Research , Inc. | Los Angeles | California | 90010 | — |
| UCLA Health | Los Angeles | California | 90095 | — |
| Care Access Santa Clarita | Newhall | California | 91321 | — |
| Hoag Hospital | Newport Beach | California | 92663 | — |
| Stanford University Medical Center | Redwood City | California | 94063 | — |
| Mills Peninsula Health Center | San Mateo | California | 94401 | — |
| Northeast Research Institute, Llc | Fleming Island | Florida | 32003 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| University of Miami | Miami | Florida | 33136 | — |
| West Orange Endocrinology | Ocoee | Florida | 34761 | — |
| Advent Health Orlando | Orlando | Florida | 32804 | — |
| Synexus Research | Orlando | Florida | 32806 | — |
| Northwestern Unviersity | Evanston | Illinois | 60611 | — |
| AHN - Avon | Avon | Indiana | 46123 | — |
| Investigators Research Group | Brownsburg | Indiana | 46112 | — |
| AHN- Franklin | Franklin | Indiana | 46131 | — |
| AHN - Greenfield | Greenfield | Indiana | 46140 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| AHN - Muncie | Muncie | Indiana | 47304 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Tulane University | New Orleans | Louisiana | 70112 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Alcanza Clinical Research, LLC | Methuen | Massachusetts | 01844 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Jefferson City Medical Group | Jefferson City | Missouri | 65109 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| IMA Clinical Research St. Louis | St Louis | Missouri | 63117 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Endocrine Associates of West Village | Long Island City | New York | 77089 | — |
| NYU Langone Gastroenterology Associates | New York | New York | 10016 | — |
| Synexus Clinical Research, New York | New York | New York | 10017 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Weill Cornell Medicine | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| M3 Wake Research | Raleigh | North Carolina | 27612 | — |
| AcellaCare Salisbury | Salisbury | North Carolina | 28144 | — |
| AcellaCare Piedmont | Statesville | North Carolina | 28625 | — |
| AcellaCare Wilmington | Wilmington | North Carolina | 28401 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Preferred PCP - Pittsburgh | Pittsburgh | Pennsylvania | 15201 | — |
| Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | 15236 | — |
| Care Access Warwick | Warwick | Rhode Island | 02886-4463 | — |
| Baylor St. Luke's Medical Center | Houston | Texas | 77030 | — |
| Biopharma Informatic, Llc | Houston | Texas | 77089 | — |
| Simcare Medical Research, Llc. | Sugar Land | Texas | 77478 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98104 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04419779, 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 Nov 13, 2025 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04419779 live on ClinicalTrials.gov.