Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561529
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
the Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Open-label Single-arm Clinical Study to Evaluate the Safety and Performance of the Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity and holds potential as a non-invasive technique for managing hepatic fibrosis This pilot prospective single-arm clinical investigation aims to evaluate the safety and performance of the Gastric Bypass Stent System for hepatic fibrosis treatment in Europe This clinical investigation and the ongoing clinical investigation Protocol number BL-RD08-040 will be used to evaluate the safety and performance of the investigational device for the intended use
Detailed Description:
None
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