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Genicular Artery Embolization for the Treatment of Knee Osteoarthritis (GAE-OA)

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ClinicalTrials.gov Identifier: NCT03491397
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Siddharth Padia, MD, University of California, Los Angeles

Brief Summary:
The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Degenerative Joint Disease of Knee Device: Embozene MicroSpheres Not Applicable

Detailed Description:
This is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic knee osteoarthritis (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. The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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.
Other Names:
  • Color-Advanced Microspheres
  • Microspheres for Embolization




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provided informed consent
  • Age ≥ 40 years and less than 80 years
  • Life expectancy greater than 12 months
  • Ineligibility for or refusal of surgical management
  • Moderate-severe knee pain as determined by visual analog scale > 4
  • Osteoarthritis based on xray
  • Local knee tenderness
  • Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection)

Exclusion Criteria:• Mild knee pain as determined by visual analog scale < 4

  • Chronic renal insufficiency (serum creatinine >2 mg/dL)
  • Uncorrectable bleeding diathesis: INR >1.6, Platelets <50,000
  • Significant arterial atherosclerosis that would limit selective angiography
  • Allergy to iodinated contrast agents that is not responsive to steroid management
  • Active Infection or malignancy
  • Appropriate candidate for knee replacement surgery determined by clinical and physical examination
  • Recent (within 3 months) or active cigarette use

Information from the National Library of Medicine

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


Contacts
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Contact: Stephanie J Gilbert, BA 310-794-0376 ext 40376 SGilbert@mednet.ucla.edu
Contact: Saima Chaabane, PhD 310-794-8995 SChaabane@mednet.ucla.edu

Locations
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United States, California
Siddharth Padia, M.D. Recruiting
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Siddharth Padia, MD
Boston Scientific Corporation
Investigators
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Principal Investigator: Siddharth Padia, M.D. University of California, Los Angeles

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Responsible Party: Siddharth Padia, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03491397     History of Changes
Other Study ID Numbers: 18-000560
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Siddharth Padia, MD, University of California, Los Angeles:
Microspheres
Artery Embolization
Knee Osteoarthritis
Chronic Pain
Embozene
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases