CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 6 enrolled
Drug / intervention
Fluorescite +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03189134
NCT03189134Phase 1Completed
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Utilization of Confocal Microscopy During Cardiac Surgery

Aditya Kaza·interventional·Posted Jun 16, 2017·Updated Jul 7, 2020

In Brief

A Phase 1 clinical trial evaluating Fluorescite and Cellvizio 100 Series System with Confocal Miniprobes for Atrial Septal Defect. Completed, enrolled 6 participants across 1 site.

Detailed Summary

The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery. One of the most feared complication after heart surgery is heart block. This flexible fiberoptic confocal microscope will help discriminate between the various types of tissues in the heart and thus help avoid injury to the conduction tissue during surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Septal Defect
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 16, 2017
Enrollment StartApr 2, 2018
Primary CompletionMar 4, 2019
Study CompletionApr 26, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.0 years ago

Interventions

Fluorescitedrug

Dilute fluorescite will be applied to cardiac tissue prior to imaging

Cellvizio 100 Series System with Confocal Miniprobesdevice

Microscopy system will image cardiac tissue.