Trial Outcomes & Findings for Utilization of Confocal Microscopy During Cardiac Surgery (NCT NCT03189134)
NCT ID: NCT03189134
Last Updated: 2020-07-07
Results Overview
All adverse events will be collected and relatedness to study intervention will be determined.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
Surgery through discharge (approximately 5 days)
Results posted on
2020-07-07
Participant Flow
Participant milestones
| Measure |
Imaging Arm
Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging
Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Utilization of Confocal Microscopy During Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Imaging Arm
n=6 Participants
Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging
Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue.
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Surgery through discharge (approximately 5 days)All adverse events will be collected and relatedness to study intervention will be determined.
Outcome measures
| Measure |
Imaging Arm
n=6 Participants
Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging
Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue.
|
|---|---|
|
Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention
Experienced AE related to study intervention
|
0 Participants
|
|
Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention
Experienced AE unrelated to study intervention
|
6 Participants
|
SECONDARY outcome
Timeframe: Surgery through discharge (approximately 5 days)Evaluated by measuring increased time on bypass, rate of enrollment, and the ability to incorporate this imaging modality into standard OR procedures. The additional time on bypass and ability to incorporate the imaging into standard OR procedures was assessed for each subject. 3 additional minutes on bypass was determined as reasonable per the protocol. The ability to incorporate the imaging was considered successful when it did not interfere with the planned clinical procedure. The rate of enrollment was evaluated for the study as a whole.
Outcome measures
| Measure |
Imaging Arm
n=6 Participants
Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging
Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue.
|
|---|---|
|
Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible
|
6 Participants
|
SECONDARY outcome
Timeframe: After all participants completed the study (range 2 months to 1 year post surgery)A first reviewer selected 60 FCM images and classified them as reticulated, striated, or of poor quality (indistinguishable microstructure) with 20 images in each group. Quality of the files is measured by the ability of 8 blinded reviewers to classify the images accurately.
Outcome measures
| Measure |
Imaging Arm
n=60 Images
Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging
Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue.
|
|---|---|
|
Percentage of Agreement in Classification of FCM Images
|
90.4 % of agreement with unblinded reviewer
Interval 81.7 to 96.7
|
Adverse Events
Imaging Arm
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Imaging Arm
n=6 participants at risk
Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
Fluorescite: Dilute fluorescite will be applied to cardiac tissue prior to imaging
Cellvizio 100 Series System with Confocal Miniprobes: Microscopy system will image cardiac tissue.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 5 • From surgery until hospital discharge, up to 9 days.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • From surgery until hospital discharge, up to 9 days.
|
|
General disorders
Edema
|
33.3%
2/6 • Number of events 2 • From surgery until hospital discharge, up to 9 days.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 3 • From surgery until hospital discharge, up to 9 days.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
6/6 • Number of events 6 • From surgery until hospital discharge, up to 9 days.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • From surgery until hospital discharge, up to 9 days.
|
|
General disorders
Pain
|
100.0%
6/6 • Number of events 6 • From surgery until hospital discharge, up to 9 days.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • From surgery until hospital discharge, up to 9 days.
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Number of events 1 • From surgery until hospital discharge, up to 9 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
33.3%
2/6 • Number of events 3 • From surgery until hospital discharge, up to 9 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
2/6 • Number of events 2 • From surgery until hospital discharge, up to 9 days.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
66.7%
4/6 • Number of events 4 • From surgery until hospital discharge, up to 9 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place