SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants

Trial ID or NCT#

NCT01315119

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 3.1.0 Ability to understand and the willingness to sign a written informed consent document. 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 reconstruction. 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.
Exclusion Criteria:
  1. 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.
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Investigator(s)

Geoffrey Gurtner
Irene Wapnir, MD
Irene Wapnir, MD
Surgical oncologist, Breast surgeon, Breast specialist
Professor of Surgery (General Surgery)
Dung Nguyen
Dung Nguyen
Breast reconstructive surgeon, Plastic and reconstructive surgeon, Chest reconstructive surgeon
Clinical Professor, Surgery - Plastic & Reconstructive Surgery
Christopher H. Contag
David Kahn, M.D.
David Kahn, M.D.
Plastic surgeon, Cosmetic plastic surgeon, Facial plastic surgeon, Plastic and reconstructive surgeon, Breast reconstructive surgeon
Clinical Associate Professor, Surgery - Plastic & Reconstructive Surgery

Contact us to find out if this trial is right for you.

Contact

ccto-office@stanford.edu
650-498-7061

View on ClinicalTrials.gov