Clinical trial
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
NCT04419779 is registered in ClinicalTrials.gov with Fractyl Health Inc. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- 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
- Lead sponsor
- Fractyl Health Inc.
- Phase
- Not applicable
- Overall status
- Suspended
- Start date
- March 8, 2021
- Completion date
- January 31, 2026
- Enrollment
- 320 (estimated)
- Sites
- 58
Conditions
As the registry lists them; a condition with its own page is linked.
type 2 diabetes