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
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Device: FLARE imaging system||Early Phase 1|
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.
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Objective Flap Assessment During Reconstructive Surgery|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
|Experimental: Imaging system operation||
Device: FLARE imaging system
Testing of operation of imaging system
- System operation [ Time Frame: 2 minutes ]
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
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||John V Frangioni, MD, PhD||Beth Israel Deaconess Medical Center|