Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee (VSI-001)

May 29, 2013 updated by: VisionScope Technologies

Trial Comparing VisionScope Imaging (VSI) With Magnetic Resonance Imaging (MRI) in the Diagnosis of Suggestive Clinical Symptoms for Meniscus and Articular Cartilage Injuries in the Knee

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to accumulate efficacy data on the VisionScope Imaging System (VSI) for pre-operative diagnoses when it is used to provide illumination and visualization of articular cavities. The study will analyze the VisionScope system's accuracy compared to MRI in diagnosing and confirming meniscus tears, chondral defects, loose bodies, minor arthritis, and/or any articular or capsular trauma.

The hypothesis of the study is that the VisionScope System will be able to obtain direct visualization and diagnostic images of the intercapsular space without fluid distention in the knee. This study will provide feedback on the ability of the VisionScope system to potentially eliminate the need for MRI scans. Additionally, a cost-analysis comparison between the use of VSI vs. MRI for the diagnosis of orthopaedic knee injuries will be conducted. Finally, the study will help develop an algorithm of potential use for the VSI system in the management of knee pathologies.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90045
        • Kerlan-Jobe Orthopaedic Foundation
      • Redwood, California, United States, 94063
        • Stanford School of Medicine
      • Santa Monica, California, United States, 90404
        • Santa Monica Orthopaedic & Sports Medicine Group (SMOG)
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Research and Education Institute
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
    • Vermont
      • Morrisville, Vermont, United States, 05661
        • Mansfield Orthopaedics (Copley Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suspected meniscal injuries to the knee
  • Suspected articular cartilage injuries to the knee

Exclusion Criteria:

  • Acute traumatic hemarthroses and/or concomitant ligament injury
  • Active systemic infection
  • Allergy to silicone or any medication used during the procedure
  • Enrollment in another pharmacological or medical device study
  • Institutionalized persons, prisoners and persons with decisional incapacity
  • Investigator's own students and employees

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VisionScope Imaging (VSI) Exam
A VisionScope Imaging (VSI) Exam is diagnostic arthroscopic procedure. Through a natural or surgical opening, an endoscope is inserted through a cannula to illuminate and visualize the interior cavity of a joint.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy
Time Frame: 1 day
Diagnostic accuracy will be assessed during the time of the procedure. There will be no patient followup in this study. Radiologists, post procedure, will compare/contrast the diagnostic findings of a patient's MRI, VSI and Dx Arthroscopy.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VisionScope Technologies

Investigators

  • Principal Investigator: Thomas J Gill, IV, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VisionScope VSI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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