Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256497
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-13
First Post:
2024-02-05
Brief Title:
A Prospective Study to Evaluate Revita DMR Post Market Pilot Clinical Follow-Up Registry in Patient With Type 2 Diabetes
Sponsor:
Fractyl Health Inc
Organization:
Fractyl Health Inc
Study Overview
Official Title:
Revita DMR Post Market Pilot Clinical Registry
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Patients 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 Systems IFU of the CE marked Revita System as well as according to medical society guidelines and physician discretion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None