SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
NCT ID: NCT06550024
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
89 participants
INTERVENTIONAL
2024-11-28
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Genicular Artery Embolization (GAE)
Temporary Embolization of Genicular Arteries using Resorbable Microspheres
SakuraBead Resorbable Microspheres
Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
Corticosteroid Injection
Corticosteroid injection in the knee
Corticosteroid Injection
Corticosteroid injection in the knee
Interventions
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SakuraBead Resorbable Microspheres
Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
Corticosteroid Injection
Corticosteroid injection in the knee
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of knee OA, and
3. Moderate to severe knee pain (WOMAC Pain ≥ 10), and
4. Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
6. Age ≥ 40 years and \< 80 years, and
7. Able to comply with all treatments and follow-up visits.
Exclusion Criteria
2. Current infection of target joint, or
3. Life expectancy less than 36 months, or
4. Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
6. Prior knee replacement surgery in the target knee, or
7. Pain score of \>3 NRS on the non-target knee, or
8. An acute internal derangement of the target knee, or
9. History of uncorrectable coagulopathy, or
10. Prior iodinated contrast reaction resulting in anaphylaxis, or
11. Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
12. Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or
13. Contraindication to MRI, or
14. At the discretion of the Principal Investigator
40 Years
79 Years
ALL
No
Sponsors
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CrannMed
INDUSTRY
Responsible Party
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Locations
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University of Alabama Medicine
Birmingham, Alabama, United States
Harbor UCLA Medical Center
Torrance, California, United States
Advanced Vascular Institute
Panama City, Florida, United States
IR Centers
Raleigh, North Carolina, United States
Orthopedic and Fracture Specialists (O&FS)
Portland, Oregon, United States
IR Centers
Leesburg, Virginia, United States
Bokhua Memorial Cardiovascular Center
Tbilisi, , Georgia
Royal Berkshire NHS Foundation Trust
Reading, , United Kingdom
Nano Medical Clinic
Tashkent, Uzbekistan, Uzbekistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CI570
Identifier Type: -
Identifier Source: org_study_id
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