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

CT Scans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914585
• Other study ID #: 0001 (IRB 0485-19)
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2023
• Source: Deep Health Ltd.
• Contact: Ben Metz
• Phone: +972-546921978
• Email: ben.metz[@]deep-health.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CT Scans

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Deep Health Ltd.

Country where clinical trial is conducted

Israel, 

References & 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.2018.06.1 — View Citation

Gebhard 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. — View Citation

Mendelsohn 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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