Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal CordNCT04914585
Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test
An observational study of Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal Cord and CT Scans, run by Deep Health Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal Cord, CT Scans
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- men and women
- 18 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
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Josh Schroeder, MD
About this study
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.
Read the detailed description
In spinal surgery, there are a number of navigation technologies based on CT scans performed before surgery (or during surgery) and identify the vertebrae (using special photographs or markers on the spine), such as Mazor with the Renaissance Robotic Surgical System used in hospitals, or BrianLab Which uses non-robotic navigation and is based on a marker located on the patient's back. These technologies are not optimal, and have a number of significant drawbacks: Because during spinal surgery, there is a displacement, the level of accuracy decreases as the surgery progresses. In addition, there is extensive use of radiation in these means since in many cases CT is performed before and during surgery.
Today, in the age of optical detection, it is possible to detect three-dimensional structures in photography and allow high levels of accuracy (less than 0.5 mm). Optical scanning does not include radiation and lasts the entire length of the operation. Of the patient and of the treating staff.
- Keywords
- spinal surgery, CT scans, surgical navigation, optical tracking
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deep Health Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josh Schroeder, MD, Principal investigator, Advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914585
- Sponsor's protocol ID
- 0001 (IRB 0485-19)
- Status last verified
- Jun 2024
- First submitted
- 30 May 2021
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30257292Gebhard 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.
PubMed 15183702Mendelsohn 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.
PubMed 26686604
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test
- ClinicalTrials.gov ID
- NCT04914585
- Acronym / sponsor ID
- 0001 (IRB 0485-19)
- Keywords
- spinal surgery, CT scans, surgical navigation, optical tracking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Deep Health Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In spinal surgery, there are a number of navigation technologies based on CT scans performed before surgery (or during surgery) and identify the vertebrae (using special photographs or markers on the spine), such as Mazor with the Renaissance Robotic Surgical System used in hospitals, or BrianLab Which uses non-robotic navigation and is based on a marker located on the patient's back. These technologies are not optimal, and have a number of significant drawbacks: Because during spinal surgery, there is a displacement, the level of accuracy decreases as the surgery progresses. In addition, there is extensive use of radiation in these means since in many cases CT is performed before and during surgery.
Today, in the age of optical detection, it is possible to detect three-dimensional structures in photography and allow high levels of accuracy (less than 0.5 mm). Optical scanning does not include radiation and lasts the entire length of the operation. Of the patient and of the treating staff.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- men and women
- 18 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DEEP HEALTH's detection algorithm for optical detection of vertebrae in the spine in patients undergoing spinal surgery.
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 30257292Farah 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.
- Background: PubMed 15183702Gebhard 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.
- Background: PubMed 26686604Mendelsohn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Schroeder, MD principal investigator
Advisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal Cord and CT Scans, run by Deep Health Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ben Metz (+972-546921978, ben.metz@deep-health.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEEP HEALTH's detection algorithm for optical detection of vertebrae in the spine in patients undergoing spinal surgery. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04914585, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.