Genicular Artery Embolization for the Treatment of Knee Osteoarthritis (GAE-OA)
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|ClinicalTrials.gov Identifier: NCT03491397|
Recruitment Status : Active, not recruiting
First Posted : April 9, 2018
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis Degenerative Joint Disease of Knee||Device: Embozene MicroSpheres||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The stratification will not be randomized, but each category will be limited to 20 patients.|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis|
|Actual Study Start Date :||February 10, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: GAE OA
Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain.
Device: Embozene MicroSpheres
Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
- Safety evaluated by cumulative rates of Adverse Events [ Time Frame: 12 Months ]Cumulative rates of AEs will be estimated and will be reported. AEs will be analyzed as a composite of all AEs, composites based on major AE types or severity and as individual AE types.
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a measure of efficacy [ Time Frame: 12 Months ]The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of 17 standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.
- Changes in Visual Analog Scan (VAS) as a measure of efficacy [ Time Frame: 12 Months ]The Faces Pain Scale is a numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of "no pain" (0) to "very much pain" (10). Participant is asked to point to the face that shows how much participant hurts at the time of assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491397
|United States, California|
|Siddharth Padia, M.D.|
|Santa Monica, California, United States, 90404|
|Principal Investigator:||Siddharth Padia, M.D.||University of California, Los Angeles|