Completed

VSI-001Trial 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

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What is being tested

VisionScope Imaging (VSI) Exam

Procedure
Who is being recruted

Leg Injuries

+ Wounds and Injuries

+ Knee Injuries

From 18 to 75 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorVisionScope Technologies
Last updated: May 31, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorVisionScope Technologies
Last updated: May 31, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

105 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Leg InjuriesWounds and InjuriesKnee Injuries

Criteria

2 inclusion criteria required to participate
Suspected articular cartilage injuries to the knee

Suspected meniscal injuries to the knee

6 exclusion criteria prevent from participating
Active systemic infection

Acute traumatic hemarthroses and/or concomitant ligament injury

Allergy to silicone or any medication used during the procedure

Enrollment in another pharmacological or medical device study

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Kerlan-Jobe Orthopaedic Foundation

Los Angeles, United StatesOpen Kerlan-Jobe Orthopaedic Foundation in Google Maps

Stanford School of Medicine

Redwood City, United States

Santa Monica Orthopaedic & Sports Medicine Group (SMOG)

Santa Monica, United States

Andrews Research and Education Institute

Gulf Breeze, United States
Completed7 Study Centers