Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811235
Status:
RECRUITING
Last Update Posted:
2023-07-03
First Post:
2021-03-15
Brief Title:
Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
OMNI-SCI Trial - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This single-center prospective observational study will enroll 10 patients admitted to Vancouver General Hospital VGH for treatment of an acute traumatic spine injury
Promising preclinical data demonstrates that the oxygenation and hemodynamic measures of our Near Infra-Red Spectroscopy NIRS system closely match the invasive intraparenchymal measures obtained within the injured spinal cord Further the NIRS sensor is responsive and reflective of systemic hemodynamic changes This clinical protocol represents the first application of this novel NIRS sensor in human SCI Following operative decompression of the spinal cord via a posterior approach the NIRS sensor will be placed over the dura for 7 days to monitor spinal cord oxygenation and tissue hemodynamics Patients will be followed for 6 months and data collection for safety feasibly and efficacy of the NIRS System
The specific aims of this project are to
1 Establish the safety feasibility and efficacy of our NIRS system in monitoring tissue oxygenation and hemodynamics of the injured spinal cord in human participants
2 Complete the technical refinement of the NIRS system utilizing an iterative process guided by participant recruitment and data accrual during the trial
Promising preclinical data demonstrates that the oxygenation and hemodynamic measures of our Near Infra-Red Spectroscopy NIRS system closely match the invasive intraparenchymal measures obtained within the injured spinal cord Further the NIRS sensor is responsive and reflective of systemic hemodynamic changes This clinical protocol represents the first application of this novel NIRS sensor in human SCI Following operative decompression of the spinal cord via a posterior approach the NIRS sensor will be placed over the dura for 7 days to monitor spinal cord oxygenation and tissue hemodynamics Patients will be followed for 6 months and data collection for safety feasibly and efficacy of the NIRS System
The specific aims of this project are to
1 Establish the safety feasibility and efficacy of our NIRS system in monitoring tissue oxygenation and hemodynamics of the injured spinal cord in human participants
2 Complete the technical refinement of the NIRS system utilizing an iterative process guided by participant recruitment and data accrual during the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None