Prospective Comparative Study in Spine Surgery Between O-Arm and Airo Systems: Efficacy and Radiation Exposure.
Kaissar Farah, Pierre Coudert, Thomas Graillon...
https://pubmed.ncbi.nlm.nih.gov/30257292Actively Recruiting
Led by Deep Health Ltd. · Updated on 2025-02-05
200
Participants Needed
1
Research Sites
N/A
Total Duration
This research focuses on patients undergoing spinal surgery involving vertebrae, intervertebral discs, and the spinal cord. It evaluates a new optical detection method that uses three-dimensional imaging based on CT scans to identify vertebrae during surgery. The study is observational and aims to improve accuracy and reduce radiation exposure compared to current navigation technologies that rely on CT scans performed before or during surgery. The study assesses DEEP HEALTH's detection algorithm, which uses optical scanning to identify vertebrae with high precision (less than 0.5 mm). Unlike existing methods, this optical technique does not involve radiation and can be used continuously throughout the surgery. The optical system captures three-dimensional structures without the need for markers or extensive imaging. Participants will be patients who have spinal CT scans and are scheduled for spinal surgery. Researchers will monitor the accuracy of the optical detection algorithm over 12 months. Data collection includes CT images and surgery details. The study aims to measure how well the algorithm detects vertebrae during surgery with ongoing observation but does not involve additional treatments or interventions.
CONDITIONS
Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At the time of surgery
Participants scheduled for spinal surgery undergo CT scans and optical detection using the DEEP HEALTH algorithm to identify vertebrae in the spine.
1 visit (in-person)
Duration - 12 months
Participants are monitored to assess the accuracy and effectiveness of the optical detection algorithm over 12 months after surgery.
Total: 1 location
1
Hadassah Medical Organization
Jerusalem, Israel
Actively Recruiting
B
Ben Metz
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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