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Tissue Oxygenation Measurements With Modulated Light (S-FLARE)

NCT01116297 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2013-02-18

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Imaging with S-FLARE imaging system

Tissue oxygenation measurements during plastic surgery using the S-FLARE system.

Sponsors & Collaborators

Principal Investigators

  • John V. Frangioni, MD, PhD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116297 on ClinicalTrials.gov