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

January 30, 2011 updated by: Spectros Corporation
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 Overview

Status

Unknown

Conditions

Detailed Description

The tissue saturation of free flaps will be measured before, during, and after surgery and during recovery.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: John Griffin, MD
  • Phone Number: 650-348-1503

Study Locations

  • United States
    • California
      • Burlingame, California, United States, 94010-3282
        • Recruiting
        • Mills Penisula Hospital
        • Contact:
          • John Griffin, MD
          • Phone Number: 650-348-1503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgical breast reconstruction.

Description

Inclusion Criteria:

  • Under surgical breast reconstruction
  • Informed consent

Exclusion Criteria:

  • Failure to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Flap Failure and Compromise by Tissue Saturation Values (Efficacy)
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Oximetric Diagnosis compared to Clinical Diagnosis, Doppler
Time Frame: 72 hours
72 hours
Device Safety Measures (safety)
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectros Corporation

Collaborators

Stanford University
Mills-Peninsula Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (ESTIMATE)

July 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2011

Last Update Submitted That Met QC Criteria

January 30, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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