MedTrace Logo

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

NCT03968965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-11-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Spinal Stenosis, Lumbar Region
  • Spondylolisthesis

Interventions

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.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    collaborator OTHER

  • 7D Surgical Inc.

    lead INDUSTRY

Principal Investigators

  • Frank P Cammisa, Jr., MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2019-11-01
Completion
2019-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03968965 on ClinicalTrials.gov