CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
3D MvIGS Spine Navigation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03968965
NCT03968965N/ACompleted
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A Single-Center, Prospective Cohort Study of the Machine-vision Image Guided Surgery (MvIGS) Spine Navigation System

7D Surgical Inc.·interventional·Posted May 30, 2019·Updated Nov 1, 2021

In Brief

A clinical study evaluating 3D MvIGS Spine Navigation and 2D Fluoroscopy for Spinal Stenosis, Lumbar Region and Spondylolisthesis. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Stenosis, Lumbar Region, Spondylolisthesis
CountriesUnited States
CollaboratorsHospital for Special Surgery, New York

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 30, 2019
Enrollment StartMay 9, 2018
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.1 years ago

Interventions

3D MvIGS Spine Navigationdevice

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.

2D Fluoroscopyother

Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.