SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
NCT Number: NCT06550024
Acronym: SURE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Osteo Arthritis Knee|Joint Diseases|Musculoskeletal Diseases|Rheumatic Diseases|Arthritis|Osteoarthritis
Interventions: DEVICE: SakuraBead Resorbable Microspheres|DRUG: Corticosteroid Injection
Sponsor: CrannMed
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-04

Summary:
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).

Primary Outcome Measures: Primary Efficacy Endpoint, Change in the Western Ontario and McMaster University Osteoarthritis Index Pain (WOMAC Pain) score from baseline to 6 months. Scale: 0-20, lower score means a better outcome., 6 Months|Primary Safety Endpoint, Freedom from treatment-related serious adverse events (SAE) through 6 months following the index procedure, 6 Months
Secondary Outcome Measures: Responders, Compare the proportion of responders between the Investigational procedure and Control at 1 month, 3 months and 6 months. Responders are defined as having:

1. ≥50% reduction in Western Ontario and McMaster University Osteoarthritis Index Pain score (WOMAC Pain, Scale 0-20)

   AND
2. ≥20mm reduction in Pain measured using the Visual Analogue Scale (VAS, Scale: 0-10cm).

Note: Lower scores mean a better outcome on both scales., 1 Month, 3 months and 6 Months|Change in mean WOMAC Pain, Compare mean change from baseline in the Western Ontario and McMaster University Osteoarthritis Index Pain (WOMAC Pain, Scale: 0-20) score score between the Investigational procedure and Control at 1 and 3 months. Note: Lower scores means a better outcome., 1 Month and 3 Months|Clinical Response, Assess the number of subjects achieving clinical response at timeframe: 3 months, 12 months, and 24 months., 3 Months, 12 Months and 24 Months|Change in Visual Analogue Scale (VAS), Compare mean decrease in pain (measured using the Visual Analogue Scale (VAS)) between the Investigational procedure and Control at 1 month, 3 months and 6 months. Scale: 0-10cm, where a lower score means a better outcome., 1 Month, 3 Months and 6 Months|Change in total WOMAC, Assess the change in subjects total Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score at 3 months, 6 months, 12 months, and 24 months. Scale: 0-96, lower score means a better outcome., 6 Months, 12 Months and 24 Months|Change in WOMAC pain, Assess the change in subjects Western Ontario and McMaster University Osteoarthritis Index Pain (WOMAC Pain) score at 3 months, 6 months, 12 months, and 24 months. Scale: 0-20, lower score means a better outcome., 3 Months, 6 Months, 12 Months and 24 Months|Change in VAS Pain, Assess the change in subjects Visual Analogue Scale (VAS) score at 3 months, 6 months, 12 months, and 24 months. Scale: 0-10cm, lower scores mean better outcomes., 3 Months, 6 Months, 12 Months and 24 Months