Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05559866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-09-26
Brief Title:
Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial HAPCET A Single-center Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
HAPCET
Brief Summary:
This study is being done to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation HAPC and Endoscopic Sleeve Gastroplasty ESG for weight loss and improvement in obesity-related co-morbidities compared to ESG alone in participants with a BMI 30 and 40 kgm² who have failed to achieve and maintain weight loss with a non-surgical program
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?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None