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Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities

NCT03604029 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-09-09

No results posted yet for this study

Summary

This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations.

Conditions

  • Compartment Syndrome of Leg

Interventions

DEVICE

Near Infrared Spectroscopy

Near Infrared Spectroscopy (NIRS) sensors are applied to injured leg compartments and a control compartment to continuously measure tissue oxygenation.

Sponsors & Collaborators

  • Nonin Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Chevas R. Yeoman, MPH · The Geneva Foundation

  • William M. Reisman, MD · Emory Department of Orthopedics

  • Charles L. Ogburn, MD · Athens Orthopedic Clinic

  • Patrick M. Osborn, MD · San Anontio Military Medical Center

  • Brandon J. Yuan, MD · Mayo Clinic

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2021-06-30
Completion
2022-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03604029 on ClinicalTrials.gov