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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Device: Imaging with S-FLARE imaging system
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Tissue Oxygenation Measurements During Plastic Surgery Using Spatially Modulated Light (S-FLARE)

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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.



Enrollment: 4
Study Start Date: January 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imaging with S-FLARE imaging system
3 patients to be imaged by S-FLARE imaging system.
Device: Imaging with S-FLARE imaging system
Tissue oxygenation measurements during plastic surgery using the S-FLARE system.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116297

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: John V. Frangioni, MD, PhD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: John V. Frangioni, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01116297     History of Changes
Other Study ID Numbers: 2009-P000384 BIDMC
Study First Received: February 3, 2010
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
breast reconstruction
breast cancer
near infrared imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014