NCT03968965

Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation

A Single-Center, Prospective Cohort Study of the Machine-vision Image Guided Surgery (MvIGS) Spine Navigation System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: 7D Surgical Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults. There will be separate study arms for cases utilizing the three-dimensional (3D) MvIGS spine navigation system and cases that utilize conventional two-dimensional (2D) fluoroscopy.

Detailed description

This is a single center, randomized, prospective cohort study to comparatively evaluate the implementation of the MvIGS spine navigation system to conventional 2D fluoroscopy for pedicle screw fixation for the treatment of spinal stenosis with degenerative spondylolisthesis of the lumbar spine. Fluoroscopy and the MvIGS navigation system are both intraoperative imaging options available to aid spine surgeons. Fluoroscopy uses X-rays to obtain images of patient anatomy. The MvIGS spine navigation system provides patient specific, high quality intraoperative imaging with no radiation exposure. After the spine is exposed, intraoperative images are obtained using visible light then registered to the patient's preoperative computed tomography scan. Use of the proprietary integrated surgical light with embedded tracking technology and Instant Flash™ registration allows for continuous and direct visualization of the surgical field without disturbing surgeon workflow.

Conditions

• Spinal Stenosis, Lumbar Region
• Spondylolisthesis

Interventions

Type	Name	Description
DEVICE	3D MvIGS Spine Navigation	The 7D Surgical MvIGS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. The surgical light containing the machine vision cameras is the sole luminaire during image guided surgery.
OTHER	2D Fluoroscopy	Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.

Timeline

• Start date: 2018-05-09
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2019-05-30
• Last updated: 2021-11-01
• Results posted: 2021-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study