NCT01116297

Tissue Oxygenation Measurements With Modulated Light (S-FLARE)

Tissue Oxygenation Measurements During Plastic Surgery Using Spatially Modulated Light (S-FLARE)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Imaging with S-FLARE imaging system	Tissue oxygenation measurements during plastic surgery using the S-FLARE system.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-05-04
• Last updated: 2013-02-18

Locations

1 site across 1 country: United States