CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Not specified
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/NCT00446927
NCT00446927N/ACompleted

SPY Imaging System: Its Role in Pediatric Cardiac Surgery

Emory University·observational·Posted Mar 13, 2007·Updated May 24, 2012

In Brief

An observational study for Cardiopulmonary Bypass and Congenital Heart Defects. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The current method of evaluating the surgical repair during surgery is limited to echocardiography (a noninvasive diagnostic procedure that uses ultrasound to study the structure and motions of the heart) or an invasive procedure called cardiac catheterization. The SPY imaging system makes use of the fluorescence properties of indocyanine green (ICG) to obtain high quality images in blood vessels. ICG is a green dye used to test heart output. The use of the SPY imaging system during surgery may provide valuable information regarding successful vessel connection and the area remaining unblocked. This study will compare the results of images to echocardiography and conventional angiography results. With SPY imaging, congenital heart surgeons would be able to check the quality of the procedure and revise, redo or perform additional procedures as dictated by the images before the patient leaves the operating room.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2007
Enrollment StartApr 1, 2007
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.3 years ago