Utilization of Confocal Microscopy During Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT03189134|
Recruitment Status : Completed
First Posted : June 16, 2017
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Septal Defect||Drug: Fluorescite Device: Cellvizio 100 Series System with Confocal Miniprobes||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Utilization of Confocal Microscopy During Cardiac Surgery|
|Actual Study Start Date :||April 2, 2018|
|Actual Primary Completion Date :||March 4, 2019|
|Actual Study Completion Date :||April 26, 2019|
Experimental: 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
Dilute fluorescite will be applied to cardiac tissue prior to imaging
Other Name: fluorescein sodium
Device: Cellvizio 100 Series System with Confocal Miniprobes
Microscopy system will image cardiac tissue.
- Adverse events and rates of post-surgical complications [ Time Frame: Surgery through discharge (approximately 5 days) ]All adverse events will be collected and relatedness to study participation will be determined. Complications will be compared to average complication rates for ASD repairs.
- The logistical feasibility of conducting FCM imaging during cardiac surgery [ Time Frame: 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. All of the factors will be combined to determine feasibility.
- Quality of the FCM image files collected [ Time Frame: End of study (approximately 6 months) ]Quality will be defined as the ability of observers to distinguish features and discriminate between working myocardium and nodal tissue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189134
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Aditya K Kaza||Boston Children’s Hospital|