At a glance
ClinicalIndex Comparison RecordN/ACompleted· 24 enrolled
Drug / intervention
Colovac Colorectal Anastomosis Protection Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study: A Study to Investigate the Performance and Safety of the Colovac 2 Colorectal Anastomosis Protection Device
In Brief
A clinical study evaluating Colovac Colorectal Anastomosis Protection Device and Stoma creation for Colorectal Cancer. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesUzbekistan
Collaborators--
Timeline
N/ACompletedFinished
20252026
Enrollment StartJul 2024
First PostedAug 2024
Primary CompletionMar 2025
Study CompletionDec 2025
TodayJul 2026
First PostedAug 6, 2024
Enrollment StartJul 31, 2024
Primary CompletionMar 6, 2025
Study CompletionDec 26, 2025
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 1.9 years ago
Interventions
Colovac Colorectal Anastomosis Protection Devicedevice
A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)
Stoma creationprocedure
Diverting loop ileostomy