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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 is a NA study that has completed, run by Fractyl Health. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03653091
The ClinicalTrials.gov registry entry for NCT03653091 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fractyl Health, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Duodenal Mucosal Resurfacing (DMR) is the first listed.
NCT03653091 reports 0 study locations.
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.
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