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NCT00952107 Clinical Trial

Objective Flap Assessment During Reconstructive Surgery

Cancer Clinical Trial

Official title:
Objective Flap Assessment During Reconstructive Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00952107
Other study ID # 2009P-000095/1; BIDMC
Secondary ID
Status Completed
Phase Phase 0
First received July 31, 2009
Last updated June 11, 2012
Start date June 2009
Est. completion date February 2012

Study information
Verified date June 2012
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• FLARE imaging system
Testing of operation of imaging system

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary System operation 2 minutes No
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