Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655740
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Safety Tolerability and Effectiveness of Duodenal Mucosal RF Vapor Ablation for Insulin Elimination in Type-2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Human Study of the Safety Tolerability and Effectiveness of the Aqua Medical Circumferential RF Vapor RFV Ablation System for Duodenal Mucosal Ablation for the Management of Insulin Requiring Type-2 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEAM-IE
Brief Summary:
The purpose of this study is to determine whether RFVA of the duodenal mucosa with or without the combination of Semaglutide is a safe and effective treatment to remove the need for insulin therapy among patients with T2D who are on stable doses of insulin
Detailed Description:
This is a prospective open-label pilot to determine safety and efficacy of step-up therapy with RFVA and Semaglutide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None