Clinical trial · Interventional
Objective Flap Assessment During Reconstructive Surgery
NCT00952107CI-TRIAL-00007175completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLARE imaging system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging system operation
- interventionNames
- Device: FLARE imaging system
Primary outcomes (1)
- measure
- System operation
- timeFrame
- 2 minutes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLee BT, Hutteman M, Gioux S, Stockdale A, Lin SJ, Ngo LH, Frangioni JV. The FLARE intraoperative near-infrared fluorescence imaging system: a first-in-human clinical trial in perforator flap breast reconstruction. Plast Reconstr Surg. 2010 Nov;126(5):1472-1481. doi: 10.1097/PRS.0b013e3181f059c7. PMID 21042103