Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test

February 3, 2025 updated by: Deep Health Ltd.
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Medical Organization
        • Contact:
          • Josh Schroeder, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deep Health Ltd.

Investigators

  • Principal Investigator: Josh Schroeder, MD, Advisor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0001 (IRB 0485-19)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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