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Status unknownNCT01173133Updated Feb 1, 2011

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

An observational study in Ischemia, sponsored by Spectros Corporation. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2011-02-01.

Sponsored by Spectros Corporation · Observational

The sponsor has not verified this record recently (last verified Jan 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Ischemia

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Keywords

  • Free Flap
  • Surgery
  • Ischemia
  • Outcome
  • Reconstructive Plastic Surgery
  • Monitoring
03

In context

Ischemia

2,062 studies on the registry are indexed under Ischemia; 345 are open to participants now.

This study's planned enrollment of 50 is below the median of 184 across 618 observational studies indexed under Ischemia.

Browse Ischemia studies →

Lead sponsor

Spectros Corporation is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing surgical breast reconstruction.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Under surgical breast reconstruction
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Failure to give consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
06

What researchers measure

Primary outcomes

  1. Flap Failure and Compromise by Tissue Saturation Values (Efficacy)

    Time frame: 72 hours

Secondary outcomes

  1. Oximetric Diagnosis compared to Clinical Diagnosis, Doppler

    Time frame: 72 hours

  2. Device Safety Measures (safety)

    Time frame: 72 hours

07

Study locations

1 of 1 sites recruiting
  • Mills Penisula Hospital
    Burlingame, California 94010-3282, United States
    • John Griffin, MD · Contact · 650-348-1503
    • John Griffin, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01173133
Lead sponsor
Spectros Corporation
Collaborators
Mills-Peninsula Medical Center, Stanford University
First posted
Jul 30, 2010
Start date
Apr 2009
Primary completion
Dec 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Feb 1, 2011

Study contacts

John Griffin, MD
Contact
650-348-1503

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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