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Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Spectros Corporation.
Recruitment status was:  Recruiting
Mills-Peninsula Medical Center
Stanford University
Information provided by:
Spectros Corporation Identifier:
First received: July 28, 2010
Last updated: January 30, 2011
Last verified: January 2011
The purpose of the study is to understand the relevance of tissue oximetry measures of tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early method of detecting compromised flaps.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery

Further study details as provided by Spectros Corporation:

Primary Outcome Measures:
  • Flap Failure and Compromise by Tissue Saturation Values (Efficacy) [ Time Frame: 72 hours ]

Secondary Outcome Measures:
  • Oximetric Diagnosis compared to Clinical Diagnosis, Doppler [ Time Frame: 72 hours ]
  • Device Safety Measures (safety) [ Time Frame: 72 hours ]

Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:
The tissue saturation of free flaps will be measured before, during, and after surgery and during recovery.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgical breast reconstruction.

Inclusion Criteria:

  • Under surgical breast reconstruction
  • Informed consent

Exclusion Criteria:

  • Failure to give consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01173133

Contact: John Griffin, MD 650-348-1503

United States, California
Mills Penisula Hospital Recruiting
Burlingame, California, United States, 94010-3282
Contact: John Griffin, MD    650-348-1503      
Principal Investigator: John Griffin, MD         
Sponsors and Collaborators
Spectros Corporation
Mills-Peninsula Medical Center
Stanford University
  More Information

Responsible Party: Clinical Coordinator, Spectros Corporation Identifier: NCT01173133     History of Changes
Other Study ID Numbers: FLA-001
Study First Received: July 28, 2010
Last Updated: January 30, 2011

Keywords provided by Spectros Corporation:
Free Flap
Reconstructive Plastic Surgery

Additional relevant MeSH terms:
Pathologic Processes processed this record on May 25, 2017