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NCT01116297 · ClinicalTrials.gov registry record · Phase 1
Tissue Oxygenation Measurements With Modulated Light (S-FLARE)
A Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01116297: Completed Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
NCT01116297 is a Phase 1 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116297, a Phase 1 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DEVICE Imaging with S-FLARE imaging system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
What the finished NCT01116297 record still lists
NCT01116297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Imaging with S-FLARE imaging system is the first listed.
NCT01116297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116297 about?
NCT01116297 is a clinical study titled "Tissue Oxygenation Measurements With Modulated Light (S-FLARE)". 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.
What is the current status of trial NCT01116297?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2010-01. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01116297?
The interventions under investigation include: Imaging with S-FLARE imaging system (DEVICE).
Who is sponsoring clinical trial NCT01116297?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01116297's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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