Burlingame, California 94010

  • Ischemia

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.


Study summary:

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


Criteria:

Inclusion Criteria: - Under surgical breast reconstruction - Informed consent Exclusion Criteria: - Failure to give consent


Study is Available At:


Original ID:

FLA-001


NCT ID:

NCT01173133


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Spectros Corporation


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:April 2009
Completion Date:December 2010
Completion Type:Anticipated
Primary Completion Date:December 2010
Primary Completion Type:Anticipated
Verification Date:January 2011
Last Changed Date:January 30, 2011
First Received Date:July 28, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Device Safety Measures (safety)
Time Frame:72 hours
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Oximetric Diagnosis compared to Clinical Diagnosis, Doppler
Time Frame:72 hours
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Flap Failure and Compromise by Tissue Saturation Values (Efficacy)
Time Frame:72 hours
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Spectros Corporation
Agency Class:Other
Agency Type:Collaborator
Agency Name:Mills-Peninsula Medical Center

Samples and Retentions

Study Population: Patients undergoing surgical breast reconstruction.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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