Status:
UNKNOWN
Non-contact Intraoperative Optical Imaging During Spinal Procedures
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Computer-assisted Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Current spine procedures can suffer from a variety of complications resulting in a high incidence (up to 55%) of misplaced screws and implants. This can lead to devastating clinical consequences, incl...
Detailed Description
The hypothesis is that optical visualization of surgically exposed anatomy with the Biophotonics and Bioengineering Laboratory (BBL) surgical navigation prototype, when registered with pre-operative i...
Eligibility Criteria
Inclusion
- Greater than 18 years of age, able to provide consent, or has substitute decision maker available to consent.
- Scheduled to undergo spinal instrumentation surgery involving pedicle or lateral mass screw insertion or brain tumor resection or biopsy.
- Scheduled for pre-operative CT/ MRI scan.
- No contra-indication for a post-operative CT/MRI scan.
Exclusion
- Previous spinal decompression with significant laminectomy performed at the level intended for instrumentation
- Previous spinal decompression with laminoplasty performed at the level intended for instrumentation
Key Trial Info
Start Date :
January 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 21 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03391089
Start Date
January 21 2016
End Date
January 21 2019
Last Update
January 5 2018
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