Tissue Oxygenation Measurements With Modulated Light (S-FLARE)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
To perform a pilot study of the S-FLARE imaging system, which uses low levels of safe, invisible, near-infrared light to measure tissue oxygenation during breast reconstructive surgery and to compare S-FLARE measurements to the gold standard, FDA-approved, the ViOptix optical probe.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
4 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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