IschemiaNCT01173133
Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
An observational study of Ischemia, run by Spectros Corporation at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemia
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgical breast reconstruction.
Who may be able to join
- Under surgical breast reconstruction
- Informed consent
Who cannot join
- Failure to give consent
Trial locations and contacts
1 site in 1 country.
John Griffin, MD contact
United States1 site, 1 recruiting
- Recruiting
Mills Penisula Hospital
Burlingame, California, 94010-3282
John Griffin, MD, 650-348-1503
John Griffin, MD
About this study
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.
- Conditions
- Ischemia
- Keywords
- Free Flap, Surgery, Ischemia, Outcome, Reconstructive Plastic Surgery, Monitoring
- Medical subject headings
- Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap Failure and Compromise by Tissue Saturation Values (Efficacy)
Measured: 72 hours
Secondary outcomes (2)
Oximetric Diagnosis compared to Clinical Diagnosis, Doppler
Measured: 72 hours
Device Safety Measures (safety)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startApr 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spectros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mills-Peninsula Medical Center, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173133
- Sponsor's protocol ID
- FLA-001
- Status last verified
- Jan 2011
- First submitted
- 28 Jul 2010
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
- ClinicalTrials.gov ID
- NCT01173133
- Acronym / sponsor ID
- FLA-001
- Conditions
- Ischemia
- Keywords
- Free Flap, Surgery, Ischemia, Outcome, Reconstructive Plastic Surgery, Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Spectros CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Mills-Peninsula Medical Center, Stanford University
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The tissue saturation of free flaps will be measured before, during, and after surgery and during recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgical breast reconstruction.
Key inclusion criteria (2 listed)
- Under surgical breast reconstruction
- Informed consent
Key exclusion criteria (1 listed)
- Failure to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flap Failure and Compromise by Tissue Saturation Values (Efficacy)
Time frame: 72 hours
2 secondary outcomes
Oximetric Diagnosis compared to Clinical Diagnosis, Doppler
Time frame: 72 hours
Device Safety Measures (safety)
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Griffin, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia, run by Spectros Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Griffin, MD (650-348-1503), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flap Failure and Compromise by Tissue Saturation Values (Efficacy) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2011.