- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01116297
Tissue Oxygenation Measurements With Modulated Light (S-FLARE)
Tissue Oxygenation Measurements During Plastic Surgery Using Spatially Modulated Light (S-FLARE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This pilot study will enroll three patients who have chosen to proceed with deep inferior epigastric perforator (DIEP) flap breast reconstruction. This type of reconstruction uses skin and fat from the abdomen to reconstruct a new breast shape. The construct is vascularized through perforating arteries and veins that provide a blood supply to this tissue.
Current techniques to evaluate vessel selection rely on a handheld Doppler used for confirmation of blood flow and perfusion; however, this modality is limited as it only assesses a specific point within the flap.
The S-FLARE imaging system will be used to visualize vascularization in the DIEP flaps, and this study will compare measurements by the S-FLARE imaging system and the standard-of-care ViOptix point probe.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy.
- Women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist.
Exclusion Criteria:
- BMI > 30.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imaging with S-FLARE imaging system
3 patients to be imaged by S-FLARE imaging system.
|
Tissue oxygenation measurements during plastic surgery using the S-FLARE system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimization of Ergonomics and Functioning of the S-FLARE Imaging System during Breast Reconstructive Surgery
Time Frame: 10 minute imaging procedure
|
Due to patient-to-patient anatomic variation, the vascular perfusion to the skin in DIEP flaps is unpredictable and of great concern to the surgeon planning the flap design. We propose a method of imaging tissue oxygenation within a DIEP flap base on the use of invisible near-infrared light. This pilot study is a comparison study of oxygenation measurements taken by the ViOptix optical probe as the standard of care and the S-FLARE imaging system, with the intention of optimizing the ergonomics and functionality of the S-FLARE imaging system for use during breast reconstructive surgery. |
10 minute imaging procedure
|
Collaborators and Investigators
Investigators
- Principal Investigator: John V. Frangioni, MD, PhD, Beth Israel Deaconess Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-P000384 BIDMC
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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