Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454916
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-06
Brief Title:
Functional Lumen Opening With Self-Forming Magnetic Anastomosis
Sponsor:
GI Windows Inc
Organization:
GI Windows Inc
Study Overview
Official Title:
GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Small Bowel Anastomoses in Patients Undergoing Surgical Procedures
Status:
RECRUITING
Status Verified Date:
2024-10
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:
FLOWS
Brief Summary:
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery
Detailed Description:
This is a multicenter pivotal study in which clinical outcomes will be prospectively evaluated for a minimum of 70 subjects undergoing anastomosis creation using the Flexagon SFM system plus OTOLoc
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