Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-29 @ 10:00 PM
Study NCT ID:
NCT05010850
Status:
TERMINATED
Last Update Posted:
2025-07-03
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
Sponsor:
SafeHeal Inc
Organization:
Study Overview
Official Title:
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study: A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device
Status:
TERMINATED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Voluntary and temporary suspension of enrollment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFE-2
Brief Summary:
A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
Detailed Description:
A primary diverting stoma is widely used by surgeons in order 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 provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses 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 provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses 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:
True
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?: