Objective Flap Assessment During Reconstructive Surgery

Completed · Early Phase 1

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00952107

Run by

Beth Israel Deaconess Medical Center

People needed

6

Starts

2009-06-01

Expected to finish

2012-02-01

Last updated by the study team

2012-06-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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