Trial Outcomes & Findings for Fluorescent Evaluation of Colorectal Anastamoses (NCT NCT01424293)
NCT ID: NCT01424293
Last Updated: 2021-07-13
Results Overview
Intra-operative evaluation of bowel perfusion. Participants will be followed for the duration of hospital stay and then at 1 week and 1 month postoperatively to identify postoperative complications.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
30 days
Results posted on
2021-07-13
Participant Flow
Participant milestones
| Measure |
Indocyanine Green
1ml of intravenous ICG and imaging transanally using the Spyscope system
Indocyanine Green: 1ml of intravenous ICG and imaging transanally using the Spyscope system
The SPY® Intraoperative Imaging System
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fluorescent Evaluation of Colorectal Anastamoses
Baseline characteristics by cohort
| Measure |
Indocyanine Green
n=7 Participants
1ml of intravenous ICG and imaging transanally using the Spyscope system
Indocyanine Green: 1ml of intravenous ICG and imaging transanally using the Spyscope system
The SPY® Intraoperative Imaging System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
70.29 years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysIntra-operative evaluation of bowel perfusion. Participants will be followed for the duration of hospital stay and then at 1 week and 1 month postoperatively to identify postoperative complications.
Outcome measures
| Measure |
Indocyanine Green
n=7 Participants
1ml of intravenous ICG and imaging transanally using the Spyscope system
Indocyanine Green: 1ml of intravenous ICG and imaging transanally using the Spyscope system
The SPY® Intraoperative Imaging System
|
|---|---|
|
Evaluate the Vascular Supply of the Bowel Intra-operatively and Correlate This With Postoperative Complications Identified During Their Hospital Stay at One Week and One Month Postoperatively.
|
0 Complications
|
Adverse Events
Indocyanine Green
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place