Clinical trial · Interventional
Tissue Oxygenation Measurements With Modulated Light (S-FLARE)
Tissue Oxygenation Measurements During Plastic Surgery Using Spatially Modulated Light (S-FLARE)
NCT01116297CI-TRIAL-00009493completedPhase 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)
To perform a pilot study of the S-FLARE imaging system, which uses low levels of safe, invisible, near-infrared light to measure tissue oxygenation during breast reconstructive surgery and to compare S-FLARE measurements to the gold standard, FDA-approved, the ViOptix optical probe.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging with S-FLARE imaging system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging with S-FLARE imaging system
- description
- 3 patients to be imaged by S-FLARE imaging system.
- interventionNames
- Device: Imaging with S-FLARE imaging system
Primary outcomes (1)
- measure
- Optimization of Ergonomics and Functioning of the S-FLARE Imaging System during Breast Reconstructive Surgery
- timeFrame
- 10 minute imaging procedure
- description
- Due to patient-to-patient anatomic variation, the vascular perfusion to the skin in DIEP flaps is unpredictable and of great concern to the surgeon planning the flap design. We propose a method of imaging tissue oxygenation within a DIEP flap base on the use of invisible near-infrared light. This pilot study is a comparison study of oxygenation measurements taken by the ViOptix optical probe as the standard of care and the S-FLARE imaging system, with the intention of optimizing the ergonomics and functionality of the S-FLARE imaging system for use during breast reconstructive surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- 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: * BMI \> 30.
References
Publications (0)
Data not yet available
No reference posted for this study.