Status:
NOT_YET_RECRUITING
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
Lead Sponsor:
Deep Health Ltd.
Conditions:
Scoliosis
Scoliosis; Adolescence
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question\[s\]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental...
Detailed Description
Trial design * Allocation: Randomized * Interventional Model: Parallel Assignment (double armed) * Interventional Model Description: Dual center, prospective, randomized cohort study. * Masking: None...
Eligibility Criteria
Inclusion
- Men and women
- 16 and above years old
- Patients who are about to undergo open, instrumented spinal surgery
- Signed informed consent form
Exclusion
- Men and women
- 16 and above years old
- Patients who are about to undergo open, instrumented spinal surgery
- Signed informed consent form
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06554093
Start Date
October 30 2025
End Date
October 30 2025
Last Update
February 5 2025
Active Locations (1)
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1
Leeds Hospital
Leeds, West Yorkshire, United Kingdom, LS9 7TF