clinical trial · NCT06256497
A Prospective Study to Evaluate Revita DMR Post Market Pilot Clinical Follow-Up Registry in Patient With Type 2 Diabetes
Fractyl Health Inc.·—·suspended·n = 100
Diabetes Mellitus, Type 2Duodenal Mucosal Resurfacing (DMR)
brief summary
The Revita DMR Post Market Pilot Clinical Registry is a post-market, prospective, observational, noninterventional clinical registry in patients with T2D in Germany undergoing the Revita Procedure with the CE marked Revita System (Fractyl Health, Lexington, MA, USA) in accordance with its intended purposes. Patient's participation in this study has no impact on his or her indication or opportunity to receive therapy. Patients are to be treated in compliance with the current Revita System's IFU of the CE marked Revita System as well as according to medical society guidelines and physician discretion.
started
Jun 27, 2023
primary completion
Jul 1, 2028
completion
Dec 1, 2028
last updated
Mar 14, 2025
official title
Revita DMR Post Market Pilot Clinical Registry
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol