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SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants
Trial ID: NCT01315119
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.
The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants
3.1.0 Ability to understand and the willingness to sign a written informed consent
3.1.1 Signed written informed consent.
3.1.2 Women with local or regional recurrences after previous breast conserving surgery.
3.1.3 Women undergoing delayed post mastectomy reconstruction.
3.1.4 Women undergoing prophylactic mastectomy.
3.1.5 Women with invasive or non-invasive breast cancer, receiving breast conserving
surgery with or without reduction mammoplasty or mastectomy, with or without immediate
3.1.6 Women of 18 years of age or older.
3.1.7 ECOG or Karnofsky Performance Status 0,1,2.
3.1.8 Basic Metabolic Panel within 6 months
3.1.9 Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude the patient from meeting the study requirements.
3.2.1 History of liver or kidney failure will not be eligible.
3.2.2 Allergies to iodine containing products will not be eligible.
3.2.3 Women who are pregnant will not be eligible.
procedure: SPY Intra-Operative Angiography
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