The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants
Sponsor study identifier
Secondary identifiers
OTHER · Stanford University
observational
100
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 23, 2014
Actual (reported)Study Completion
September 23, 2015
Actual (reported)The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 23, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 11, 2011
Actual (reported)March 15, 2011
Actual (reported)June 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 23, 2014
Actual (reported)September 23, 2015
Actual (reported)To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
During surgery
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Immediately post operative
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
2 weeks
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
1 month
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
3 months
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
6 months
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
12 months
Establish the percentage of patients with ischemia or necrosis in the first year post surgery.
12 months
Number and type of complications in the first year.
12 months
Calculated per patient
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The patient population includes women with unilateral or bilateral breast cancer undergoing immediate or delayed breast reconstruction.
Stanford University School of Medicine
Stanford, California, 94305, United States
Geoffrey C. Gurtner
Stanford University
100 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2011
First Posted
March 15, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Delayed-Delayed Breast Reconstruction
Contact the study team to confirm eligibility.
Primary Completion
September 23, 2014
Actual (reported)Study Completion
September 23, 2015
Actual (reported)Last Updated
August 6, 2021
Record last verified: 2020-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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