Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test
1 other identifier
observational
200
1 country
1
Brief Summary
CT scans of the spine include vertebrae, intervertebral discs and the spinal cord. These tests are performed in an orderly protocol and allow for three-dimensional reconstruction of the vertebra in sagittal and coronal guides.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2021
CompletedFirst Posted
Study publicly available on registry
June 4, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 5, 2025
June 1, 2024
4.3 years
May 30, 2021
February 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DEEP HEALTH's detection algorithm for optical detection of vertebrae in the spine in patients undergoing spinal surgery.
Verify an algorithm for automatic detection of vertebrae in the spine, while building an optical model for optical identification in the operating room, and reducing the need for radiation use during spinal surgery.
12 months
Eligibility Criteria
Candidates for spinal surgery in the Orthopedics department at Hadassah medical center who have a previous CT scan of the spine. The participant will receive an explanation and will undergo a process of informed consent.
You may qualify if:
- men and women
- and above years old
- Patients who have available spinal CT tests will be included in the study
- Patients who are about to undergo spinal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deep Health Ltd.lead
Study Sites (1)
Hadassah Medical Organization
Jerusalem, Israel
Related Publications (3)
Farah K, Coudert P, Graillon T, Blondel B, Dufour H, Gille O, Fuentes S. Prospective Comparative Study in Spine Surgery Between O-Arm and Airo Systems: Efficacy and Radiation Exposure. World Neurosurg. 2018 Oct;118:e175-e184. doi: 10.1016/j.wneu.2018.06.148. Epub 2018 Jul 3.
PMID: 30257292BACKGROUNDGebhard F, Weidner A, Liener UC, Stockle U, Arand M. Navigation at the spine. Injury. 2004 Jun;35 Suppl 1:S-A35-45. doi: 10.1016/j.injury.2004.05.009.
PMID: 15183702BACKGROUNDMendelsohn D, Strelzow J, Dea N, Ford NL, Batke J, Pennington A, Yang K, Ailon T, Boyd M, Dvorak M, Kwon B, Paquette S, Fisher C, Street J. Patient and surgeon radiation exposure during spinal instrumentation using intraoperative computed tomography-based navigation. Spine J. 2016 Mar;16(3):343-54. doi: 10.1016/j.spinee.2015.11.020. Epub 2015 Dec 10.
PMID: 26686604BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Josh Schroeder, MD
Advisor
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2021
First Posted
June 4, 2021
Study Start
October 1, 2021
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
February 5, 2025
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share