Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective, single-centre, single-arm, unmasked, First in Human study that aims to evaluate the safety and efficacy of SakuraBead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis.
To evaluate safety and efficacy of SakuraBead for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on up to 15 patients who will be followed up for a period of 6 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genicular Artery Embolization (GAE) | Experimental | Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SakuraBead Resorbable Microspheres | Device | Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up. | 1 month | |
| Genicular Artery Embolization (GAE) without a major device- or procedure-related complication at 1 month follow-up | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in global Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire at 1 month, 3 months and 6 months follow-up | 1, 3 and 6 months | |
| Reduction of previously initiated OsteoArthritis (OA) medical therapy at 3- and 6-months follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Republican Specialized Scientific and Practical Medical Center of Therapy and Medical Rehabilitation | Tashkent | Uzbekistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 and 6 months |
| Decrease of pain on Visual Analogue Scale (VAS) at 3 and 6 months | 3 and 6 months |
| No major device- or procedure-related complication at 3 and 6 months | 3 and 6 months |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001168 | Arthritis |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided