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Objective Flap Assessment During Reconstructive Surgery

Objective Flap Assessment During Reconstructive Surgery

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00952107
Enrollment
6
Registered
2009-08-04
Start date
2009-06-30
Completion date
2012-02-29
Last updated
2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

breast cancer, breast reconstructive surgery, flap assessment

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.

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.

Interventions

DEVICEFLARE imaging system

Testing of operation of imaging system

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
System operation2 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026