Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
Megadott ok: Following an SAE, a sensor refinement process was initiated. Although the SAE appears unrelated to the device, the refined sensor did not meet sensitivity/performance required for clinical use. It was deemed most appropriate to terminate the study.
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A vizsgálat adatai
- Ki végzi
- University of British Columbia
- Azonosító
- NCT04811235
- A regiszteradat frissítve
- 2026. szeptember 23.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
"OMNI-SCI" Trial - "Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury" Trial
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.
Bevonási feltételek: Male or female aged 17 years or older; Spinal injury between bony levels C3 and L1 inclusive; Motor complete acute traumatic SCI (AIS A or B) or motor incomplete SCI (AIS C) with a total lower extremity motor score of less than 5; Blunt (non-penetrating) SCI requiring posterior laminectomy with stabilization/fusion surgery within 72 hours of injury; Able to communicate in English and provide informed consent.
Kizáró feltételek: Spinal cord impairment secondary to tumour, infection, epidural bleeding, or ischemia (in; Any condition or injury (e.g. Morel-Lavellee lesion) that would interfere with the application or readings of the NIRS sensor; Associated traumatic condition that would interfere with the informed consent process or outcome assessments (e.g. traumatic brain injury, pelvic, abdominal, or thoracic injuries); Any other medical condition that, in the investigator's opinion, would render the protocol procedures dangerous; Isolated radiculopathy or cauda equina injury; Female patients who are pregnant.