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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01173133
First Posted: July 30, 2010
Last Update Posted: February 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mills-Peninsula Medical Center
Stanford University
Information provided by:
Spectros Corporation
  Purpose
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.

Condition
Ischemia

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
Criteria

Inclusion Criteria:

  • Under surgical breast reconstruction
  • Informed consent

Exclusion Criteria:

  • Failure to give consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173133


Contacts
Contact: John Griffin, MD 650-348-1503

Locations
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
ClinicalTrials.gov Identifier: NCT01173133     History of Changes
Other Study ID Numbers: FLA-001
First Submitted: July 28, 2010
First Posted: July 30, 2010
Last Update Posted: February 1, 2011
Last Verified: January 2011

Keywords provided by Spectros Corporation:
Free Flap
Surgery
Ischemia
Outcome
Reconstructive Plastic Surgery
Monitoring

Additional relevant MeSH terms:
Ischemia
Pathologic Processes