Utilization of Confocal Microscopy During Cardiac Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03189134|
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : March 4, 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)|
|Estimated 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|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||August 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
|Contact: Ashley E Kuniholmfirstname.lastname@example.org|
|Contact: Leah Chengemail@example.com|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Ashley Kuniholm 617-355-6513 firstname.lastname@example.org|
|Contact: Leah Cheng 857-218-4731 email@example.com|
|Principal Investigator: Aditya K Kaza, MD|
|Principal Investigator:||Aditya K Kaza||Boston Children’s Hospital|