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Effects of a Spine Navigation System on Op-time and Radiation Exposure

NCT04461964 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-06-13

No results posted yet for this study

Summary

The goal of this study is to prospectively collect information about the operative time and intraoperative radiation experienced by patients undergoing posterior spinal fusion procedures guided by the MvIGS spine navigation system.

Conditions

  • Spinal Stenosis
  • Scoliosis
  • Spondylolisthesis

Interventions

DEVICE

Machine-vision Image Guided Surgery (MvIGS) spine navigation system.

The intended use of the MvIGS navigation system is to provide high quality intraoperative imaging with no radiation exposure. Use of the proprietary integrated surgical light with embedded tracking technology and Flash™ registration allows for continuous and direct visualization of the surgical field. The MvIGS system is exempt from IDE regulations as the device cleared Premarket Notification FDA-510(k) (K162375). The device includes: * A single mobile cart with a boom arm and an integrated surgical light with embedded tracking technology (P/N 10-0001); * Proprietary imaging software (P/N 60-0007); and, * Kit of tacked surgical instruments including a spine reference clamp, awl tip, pedicle probe (P/N 11-0006).

Sponsors & Collaborators

Principal Investigators

  • Jeffrey A Goldstein, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2023-02-28
Completion
2023-06-30

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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 NCT04461964 on ClinicalTrials.gov