Tissue Oxygenation Measurements With Modulated Light (S-FLARE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Imaging with S-FLARE imaging system

3 patients to be imaged by S-FLARE imaging system.

Group Type EXPERIMENTAL

Imaging with S-FLARE imaging system

Intervention Type DEVICE

Tissue oxygenation measurements during plastic surgery using the S-FLARE system.

Interventions

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Imaging with S-FLARE imaging system

Tissue oxygenation measurements during plastic surgery using the S-FLARE system.

Intervention Type DEVICE

Eligibility Criteria

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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.