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| Name | Class |
|---|---|
| Next Biomedical Co., Ltd. | INDUSTRY |
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Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator |
| |
| Device: GAE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genicular artery embolization | Device | genicular artery embolization |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living. | 6 and 12-month post treatment |
| Serious Adverse Events (SAE) | Treatment, 1,3,6,9 and 12-month post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC total score | Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living | 9 month post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziv J Haskal, MD | Contact | 16463691570 | haskalembo@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| Corticosteroid Injection |
| Drug |
Corticosteroid Injection |
|
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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