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.
Procedure: SPY Intra-Operative Angiography
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Full eligibility criteria for NCT01315119
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
1.0 Ability to understand and the willingness to sign a written informed consent document.
1.1 Signed written informed consent.
1.2 Women with local or regional recurrences after previous breast conserving surgery.
1.3 Women undergoing delayed post mastectomy reconstruction.
1.4 Women undergoing prophylactic mastectomy.
1.5 Women with invasive or non-invasive breast cancer, receiving breast conserving surgery with or without reduction mammoplasty or mastectomy, with or without immediate reconstruction.
1.6 Women of 18 years of age or older.
1.7 ECOG or Karnofsky Performance Status 0,1,2.
1.8 Basic Metabolic Panel within 6 months
1.9 Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
2.1 History of liver or kidney failure will not be eligible.
2.2 Allergies to iodine containing products will not be eligible.
2.3 Women who are pregnant will not be eligible.
All locations for NCT01315119
United States (1)
Stanford University School of Medicine
Stanford, California, United States, 94305
View full eligibility
Tris trial is registered with FDA with number: NCT01315119. The sponsor of the trial is Stanford University and it is looking for 100 volunteers for the current phase.
Official trial title: The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants
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