Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540807
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
SafeHeal Anastomosis Feasibility Evaluation SAFE-2023 Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SafeHeal Anastomosis Feasibility Evaluation SAFE-2023 Study A Study to Investigate the Performance and Safety of the Colovac 2 Colorectal Anastomosis Protection Device
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:
A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer
Detailed Description:
A primary diverting stoma is widely used by surgeons to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks Typically a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit
Colovac is a local temporary minimally invasive bypass device that protects the anastomosis and safely postpones stoma creation for 10 days after surgery By postponing stoma creation for 10 days Colovac allows stoma avoidance in all patients except those whose anastomosis have not healed by 10 days after surgery allowing the others to return to normal activity more quickly and safely
Colovac is a local temporary minimally invasive bypass device that protects the anastomosis and safely postpones stoma creation for 10 days after surgery By postponing stoma creation for 10 days Colovac allows stoma avoidance in all patients except those whose anastomosis have not healed by 10 days after surgery allowing the others to return to normal activity more quickly and safely
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