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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VisionScope Technologies
ClinicalTrials.gov Identifier:
NCT01695720
First received: September 13, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Meniscus Tears
Loose Bodies
Articular Osteoarthritis
Articular or Capsular Trauma
Procedure: VisionScope Imaging (VSI) Exam

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by VisionScope Technologies:

Primary Outcome Measures:
  • Diagnostic Accuracy [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Enrollment: 105
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695720

Locations
United States, California
Kerlan-Jobe Orthopaedic Foundation
Los Angeles, California, United States, 90045
Stanford School of Medicine
Redwood, California, United States, 94063
Santa Monica Orthopaedic & Sports Medicine Group (SMOG)
Santa Monica, California, United States, 90404
United States, Florida
Andrews Research and Education Institute
Gulf Breeze, Florida, United States, 32561
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30329
United States, Texas
University of Texas SouthWestern
Dallas, Texas, United States, 75390
United States, Vermont
Mansfield Orthopaedics (Copley Hospital)
Morrisville, Vermont, United States, 05661
Sponsors and Collaborators
VisionScope Technologies
Investigators
Principal Investigator: Thomas J Gill, IV, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: VisionScope Technologies
ClinicalTrials.gov Identifier: NCT01695720     History of Changes
Other Study ID Numbers: VisionScope VSI-001
Study First Received: September 13, 2012
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by VisionScope Technologies:
Knee Injuries
Meniscus Injuries
Articular Cartilage Injuries
Orthopaedic Diagnostic
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Osteoarthritis
Wounds and Injuries
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014