Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06915818
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery
Sponsor:
GI Windows, Inc.
Organization:
Study Overview
Official Title:
GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures
Status:
RECRUITING
Status Verified Date:
2025-11
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:
FOCUS
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 Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.
Detailed Description:
This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: