SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization (NCT06550024) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
United States89 participantsStarted 2024-11-28
Plain-language summary
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Who can participate
Age range40 Years – 79 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Severe knee OA (Kellgren-Lawrence grade 4), or
✕. Current infection of target joint, or
✕. Life expectancy less than 36 months, or
✕. 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
✕. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
✕. Prior knee replacement surgery in the target knee, or
✕
What they're measuring
1
Primary Efficacy Endpoint - Proportion of Responders
Timeframe: 6 Months
2
Primary Safety Endpoint - Freedom from treatment-related SAEs