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Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee

NCT01695720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2013-05-31

No results posted yet for this study

Summary

The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries). The study will compare VSI's accuracy to MRI's in diagnosing the same injuries.

The hypothesis is the VisionScope Imaging system will be able to provide direct visualization and diagnostic images of inside the joint capsule space without fluid distention in the knee. This study will provide valuable feedback on the ability of the VisionScope system to provide physicians with the information they need to make a definitive diagnosis.

Conditions

  • Meniscus Tears
  • Loose Bodies
  • Articular Osteoarthritis
  • Articular or Capsular Trauma

Interventions

PROCEDURE

VisionScope Imaging (VSI) Exam

The VisionScope Imaging (VSI) Exam \[the system itself\] is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization, and the capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening.

Sponsors & Collaborators

  • VisionScope Technologies

    lead INDUSTRY

Principal Investigators

  • Thomas J Gill, IV, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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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 NCT01695720 on ClinicalTrials.gov