SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 79
Healthy Volunteers: f
View:
• Subject is able and willing to provide written informed consent, and
• Clinical diagnosis of knee OA, and
• Moderate to severe knee pain (WOMAC Pain ≥ 10), and
• Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
• Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
• Age ≥ 40 years and \< 80 years, and
• Able to comply with all treatments and follow-up visits.
Locations
United States
Alabama
University of Alabama Medicine
RECRUITING
Birmingham
California
Harbor UCLA Medical Center
RECRUITING
Torrance
Florida
Advanced Vascular Institute
RECRUITING
Panama City
North Carolina
IR Centers
RECRUITING
Raleigh
Oregon
Orthopedic and Fracture Specialists (O&FS)
WITHDRAWN
Portland
Virginia
IR Centers
RECRUITING
Leesburg
Other Locations
Georgia
Bokhua Memorial Cardiovascular Center
RECRUITING
Tbilisi
United Kingdom
Royal Berkshire NHS Foundation Trust
RECRUITING
Reading
Uzbekistan
Nano Medical Clinic
RECRUITING
Tashkent
Contact Information
Primary
Chief Operations Officer
joan.mccabe@crannmed.com
+1 800 353 4246
Time Frame
Start Date: 2024-11-28
Estimated Completion Date: 2027-04
Participants
Target number of participants: 89
Treatments
Experimental: Genicular Artery Embolization (GAE)
Temporary Embolization of Genicular Arteries using Resorbable Microspheres
Active_comparator: Corticosteroid Injection
Corticosteroid injection in the knee
Related Therapeutic Areas
Sponsors
Leads: CrannMed