Status:
TERMINATED
Spine Registration Using 3D Scanning - Arise
Lead Sponsor:
Advanced Scanners Inc.
Conditions:
Spinal Fusion
Spondylolisthesis
Eligibility:
All Genders
18+ years
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.
- Have had a CT scan performed prior to the procedure.
- Clinically planned for spine surgery.
- Able to provide written informed consent from subject, using IRB approved consent form, and agrees to comply with protocol requirements.
Exclusion
- Language problems that would prevent from properly understanding instructions.
- Patients less than 18 years of age.
- 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 :
January 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05195593
Start Date
January 5 2022
End Date
June 30 2023
Last Update
October 2 2025
Active Locations (1)
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1
Arise Austin Medical Center
Austin, Texas, United States, 78746