Tissue Oxygenation Measurements With Modulated Light (S-FLARE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John V. Frangioni, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01116297
First received: February 3, 2010
Last updated: February 14, 2013
Last verified: February 2013

February 3, 2010
February 14, 2013
January 2010
February 2013   (final data collection date for primary outcome measure)
Optimization of Ergonomics and Functioning of the S-FLARE Imaging System during Breast Reconstructive Surgery [ Time Frame: 10 minute imaging procedure ] [ Designated as safety issue: Yes ]

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.

Same as current
Complete list of historical versions of study NCT01116297 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tissue Oxygenation Measurements With Modulated Light (S-FLARE)
Tissue Oxygenation Measurements During Plastic Surgery Using Spatially Modulated Light (S-FLARE)

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Device: Imaging with S-FLARE imaging system
Tissue oxygenation measurements during plastic surgery using the S-FLARE system.
Experimental: Imaging with S-FLARE imaging system
3 patients to be imaged by S-FLARE imaging system.
Intervention: Device: Imaging with S-FLARE imaging system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01116297
2009-P000384 BIDMC
No
John V. Frangioni, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: John V. Frangioni, MD, PhD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP