Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272201
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-14
Brief Title:
Incisionless Suture Plications in a POSE20 Interventional Randomized Obesity Study
Sponsor:
USGI Medical
Organization:
USGI Medical
Study Overview
Official Title:
Incisionless Suture Plications in a POSE20 Interventional Randomized Obesity Study The INSPIRO Study
Status:
NOT_YET_RECRUITING
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:
INSPIRO
Brief Summary:
This is a multi-center open-label 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure The intent is to evaluate the safety and effectiveness of POSE20 sutures placed in the mid distal body without placement in the fundus with a moderate intensity diet and exercise program as compared to diet and exercise alone The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors AKA g-Cath or g-Cath EZ and associated devices g-Prox EZ g-Lix and Transport known collectively as the Incisionless Operating Platform IOP
Detailed Description:
This is a multi-center open-label 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure The intent is to evaluate the safety and effectiveness of POSE20 g-Cath EZ Snowshoe Suture Anchors placed in the mid distal body without placement in the fundus with a moderate intensity diet and exercise program as compared to diet and exercise alone The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors AKA g-Cath or g-Cath EZ and associated devices g-Prox EZ g-Lix and Transport known collectively as the Incisionless Operating Platform IOP
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?:
None
Is an FDA AA801 Violation?:
None