NCT03391024

Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure

Completed NA Last updated 5 January 2018

What this trial tests

NA trial testing BBL Experimental Navigation System in Computer-assisted Surgery in 40 participants. Completed in 1 August 2015.

Timeline

24 September 2013

Primary endpoint
1 August 2015

1 August 2015

Quick facts

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	24 September 2013
Primary completion	1 August 2015
Estimated completion	1 August 2015
Sites	1 location across Canada

Drugs / interventions tested

• BBL Experimental Navigation System

Conditions studied

• Computer-assisted Surgery — all drugs for Computer-assisted Surgery →

Sponsor

Sunnybrook Health Sciences Centre — full company profile →

Who can join

18 and older, any sex, with Computer-assisted Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For a significant number of patients suffering from back pain, even basic daily activities become impossible. It is at this time that spinal surgery becomes necessary in order to improve the patient's quality of life. To combat these symptoms, surgical implants (e.g. pedicle screws, rods, etc.) are used to aid in stabilizing and correcting the deformities of the spine, particularly after spinal decompression. Surgical navigation has a great potential to improve the accuracy of correctly implanting these devices; however, present technologies rely on intraoperative imaging that uses ionizing radiation (e.g. computed tomography, fluoroscopy, etc.), require cumbersome set-ups, the physical attachment of fiducial markers, and cannot account for patient motion. Therefore, the investigators propose a real-time intraoperative optical topographical imaging based surgical guidance system capable of accurately guiding the placement of implanted devices such as pedicle screws.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. High Speed, High Density Intraoperative 3D Optical Topographical Imaging with Efficient Registration to MRI and CT for Craniospinal Surgical Navigation.
   Jakubovic R, Guha D, Gupta S, Lu M, et al · · 2018 · cited 29× · PMID 30291261 · DOI 10.1038/s41598-018-32424-z