Recruiting

T-Stat

Sponsor:

Spectros Corporation

Code:

NCT01173133

Conditions

Ischemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Ischemia

Study ID

NCT01173133

Start date

Apr, 2009

Status verified date

Jan, 2011

Completion date

Dec, 2010

Anticipated

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Under surgical breast reconstruction
  • Informed consent

Exclusion Criteria:

  • Failure to give consent

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

John Griffin, MD

650-348-1503

Locations

Mills Penisula Hospital

Recruiting

Burlingame, California, United States, 94010-3282

Contacts

John Griffin, MD

650-348-1503

Principal Investigator:

John Griffin, MD

More Information

Sponsor

Spectros Corporation

Last update posted

Feb 1, 2011

Last verified

Jan, 2011

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spectros Corporation on 2011-02-01.