Objective Flap Assessment During Reconstructive Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Device: FLARE imaging system |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Objective Flap Assessment During Reconstructive Surgery |
- System operation [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
| Enrollment: | 6 |
| Study Start Date: | June 2009 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Imaging system operation |
Device: FLARE imaging system
Testing of operation of imaging system
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided by Beth Israel Deaconess Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | John V. Frangioni, Principal Investigator, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00952107 History of Changes |
| Other Study ID Numbers: | 2009P-000095/1; BIDMC |
| Study First Received: | July 31, 2009 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Beth Israel Deaconess Medical Center:
|
breast cancer breast reconstructive surgery flap assessment |
ClinicalTrials.gov processed this record on May 16, 2013