Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03653091 · ClinicalTrials.gov registry record · NA
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
A NA study, sponsored by Fractyl Health.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT03653091: Completed NA study, sponsored by Fractyl Health.
NCT03653091 is a NA study that has completed, run by Fractyl Health. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03653091, a NA study, has completed, sponsored by Fractyl Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. The purpose of this study is to demonstrate the safety and effectiveness of the Fractyl DMR Procedure using the Revita™ System compared to a sham procedure. At 24 weeks, subjects randomized to the DMR procedure be continued to be followed per protocol till 48 Weeks and the Sham treatment arm will be offered to cross over to receive the DMR treatment and will be followed per protocol for 24 weeks post treatment.
Primary Outcome
Change in HbA1c from baseline in DMR vs Sham groups
Interventions
- DEVICE Duodenal Mucosal Resurfacing (DMR)
- DEVICE Duodenal Mucosal Resurfacing Sham (Sham)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-09-28 |
| Est. Completion | 2020-08-10 |
| Phase | NA |
What the finished NCT03653091 record still lists
NCT03653091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Duodenal Mucosal Resurfacing (DMR) is the first listed.
NCT03653091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03653091 about?
NCT03653091 is a clinical study titled "Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes". The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. The purpose of this study is to demonstrate the safety and effectiven...
What is the current status of trial NCT03653091?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2018-09-28. Estimated completion is 2020-08-10.
What interventions are being tested in trial NCT03653091?
The interventions under investigation include: Duodenal Mucosal Resurfacing (DMR) (DEVICE), Duodenal Mucosal Resurfacing Sham (Sham) (DEVICE).
Who is sponsoring clinical trial NCT03653091?
This trial is sponsored by Fractyl Health, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03653091's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI