Status:
COMPLETED
Objective Flap Assessment During Reconstructive Surgery
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Cancer
Eligibility:
All Genders
21+ years
Phase:
EARLY_PHASE1
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 ...
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 (D...
Eligibility Criteria
Inclusion
- 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
- Patients with a known or suspected iodide or seafood allergy.
- Patients with known renal, cardiac, hepatic, or pulmonary disease.
- BMI \> 30
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00952107
Start Date
June 1 2009
End Date
February 1 2012
Last Update
June 13 2012
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215