Status:
TERMINATED
Spine Registration Using 3D Scanning
Lead Sponsor:
Advanced Scanners Inc.
Conditions:
Spinal Fusion
Spinal Stenosis
Eligibility:
All Genders
Brief Summary
The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.
Eligibility Criteria
Inclusion
- Patients that require exposure of bony posterior spine anatomy for localization as standard of care.
- Clinically planned for spine surgery.
- Able to provide written informed consent from subject or subject's legal representative, using IRB approved consent form, and ability for subject to comply with the protocol requirements of the study.
Exclusion
- Language problems that would prevent from properly understanding instructions.
- Requirement of an interpreter.
- Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
- Special populations: pregnant women, prisoners.
- Minimally invasive spine surgery that does not expose the necessary bone/s.
- Spine surgery without posterior exposure.
Key Trial Info
Start Date :
August 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 2 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05195580
Start Date
August 31 2021
End Date
November 2 2021
Last Update
October 2 2025
Active Locations (1)
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1
St. David's Round Rock Medical Center
Round Rock, Texas, United States, 78681