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Tissue Oxygenation Measurements With Modulated Light (S-FLARE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01116297
First Posted: May 4, 2010
Last Update Posted: February 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John V. Frangioni, Beth Israel Deaconess Medical Center
  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
Intervention Model: Single Group Assignment
Masking: None (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 John V. Frangioni, 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 ]

    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

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: February 3, 2010
First Posted: May 4, 2010
Last Update Posted: February 18, 2013
Last Verified: February 2013

Keywords provided by John V. Frangioni, Beth Israel Deaconess Medical Center:
breast reconstruction
breast cancer
near infrared imaging


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