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Objective Flap Assessment During Reconstructive Surgery

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ClinicalTrials.gov Identifier: NCT00952107
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
John V. Frangioni, Beth Israel Deaconess Medical Center

Brief Summary:
The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.

Condition or disease Intervention/treatment Phase
Cancer Device: FLARE imaging system Early Phase 1

Detailed Description:

To perform a pilot study of the FLARE™ NIR fluorescence imaging system in conjunction with indocyanine green (ICG) during breast reconstructive surgery utilizing deep inferior epigastric perforator (DIEP) flaps.

Due to patient-to-patient anatomic variation, the vascular perfusion to the cutaneous elements in flaps is unpredictable and of great concern to the surgeon planning the design of the flap. We propose a method of imaging the flap based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon.

Specific Aims:

A pilot optimization study of the imaging system in combination with ICG to determine optimal dose, light excitation fluence rate, and camera exposure time.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Objective Flap Assessment During Reconstructive Surgery
Study Start Date : June 2009
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Imaging system operation Device: FLARE imaging system
Testing of operation of imaging system



Primary Outcome Measures :
  1. System operation [ Time Frame: 2 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  • Patients with a known or suspected iodide or seafood allergy.
  • Patients with known renal, cardiac, hepatic, or pulmonary disease.
  • BMI > 30

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): NCT00952107


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John V. Frangioni, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00952107     History of Changes
Other Study ID Numbers: 2009P-000095/1; BIDMC
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by John V. Frangioni, Beth Israel Deaconess Medical Center:
breast cancer
breast reconstructive surgery
flap assessment