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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 is a Phase 1 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 4 participants.

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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.

Interventions

  • DEVICE Imaging with S-FLARE imaging system

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2010-01
Est. Completion 2013-02
Phase Phase 1

What the Registry Record Tells You About NCT01116297

The ClinicalTrials.gov registry entry for NCT01116297 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Imaging with S-FLARE imaging system is the first listed.

NCT01116297 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.