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Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial

NCT04811235 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-07-03

No results posted yet for this study

Summary

The study involves the 'first-in-human' evaluation of a novel optical sensor which uses near-infrared spectroscopy (NIRS) technology to assess oxygenation and hemodynamics of the injured spinal cord. The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time. Our testing of this novel NIRS sensor in patients with acute SCI represents the first step in translating this technology for human use.

Conditions

  • Acute Spinal Cord Injury
  • Spinal Cord Injuries

Interventions

DEVICE

Near Infra-Red Spectroscopy (NIRS) Sensor

The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Brian Kwon, MD · University of British Columbia

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-24
Primary Completion
2024-06-02
Completion
2024-09-30

Countries

  • Canada

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 NCT04811235 on ClinicalTrials.gov