Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee
Completed · Not applicable
Conditions studied: Meniscus Tears, Loose Bodies, Articular Osteoarthritis, Articular or Capsular Trauma
In brief
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.
Key facts
- Study ID
- NCT01695720
- Run by
- VisionScope Technologies
- People needed
- 105
- Starts
- 2012-06-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2013-05-31
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Suspected meniscal injuries to the knee
- Suspected articular cartilage injuries to the knee
You may not qualify if…
- 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
Where it is running
- Kerlan-Jobe Orthopaedic Foundation — Los Angeles, California, United States
- Stanford School of Medicine — Redwood City, California, United States
- Santa Monica Orthopaedic & Sports Medicine Group (SMOG) — Santa Monica, California, United States
- Andrews Research and Education Institute — Gulf Breeze, Florida, United States
- Emory University Hospital — Atlanta, Georgia, United States
- University of Texas SouthWestern — Dallas, Texas, United States
- Mansfield Orthopaedics (Copley Hospital) — Morrisville, Vermont, United States
Full record on ClinicalTrials.gov
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