Trial Outcomes & Findings for SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study (NCT NCT06540807)
NCT ID: NCT06540807
Last Updated: 2026-05-20
Results Overview
Rate of clinically significant device migration The rate of subjects for which the device has migrated clinically significant during its 10-day implant period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
10 days
Results posted on
2026-05-20
Participant Flow
Participant milestones
| Measure |
Colovac
The Colovac device will be implanted for approximately 10 days.
Colovac Colorectal Anastomosis Protection Device: 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 creation: Diverting loop ileostomy
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Colovac
n=24 Participants
The Colovac device will be implanted for approximately 10 days.
Colovac Colorectal Anastomosis Protection Device: 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 creation: Diverting loop ileostomy
|
|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 12.8 • n=24 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=24 Participants
|
|
Region of Enrollment
Uzbekistan
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Patients treated with Colovac
Rate of clinically significant device migration The rate of subjects for which the device has migrated clinically significant during its 10-day implant period.
Outcome measures
| Measure |
Colovac
n=24 Participants
Patients who were treated with the Colovac Device.
|
|---|---|
|
Migration
|
2 Participants
|
Adverse Events
Colovac
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Colovac
n=24 participants at risk
Patients who were treated with the Colovac Device.
|
|---|---|
|
General disorders
Bleeding
|
4.2%
1/24 • Number of events 1 • 1 month
|
|
Gastrointestinal disorders
Anastomotic Leak
|
16.7%
4/24 • Number of events 4 • 1 month
|
Other adverse events
| Measure |
Colovac
n=24 participants at risk
Patients who were treated with the Colovac Device.
|
|---|---|
|
General disorders
Fever
|
12.5%
3/24 • Number of events 4 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place