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This is a prospective, single center, double arm, randomized, unmasked, First in Human study that aims to evaluate the safety and effectiveness of SakuraBeadâ„¢ resorbable embolization microspheres in adult patients suffering from pain secondary to plantar fasciitis.
To compare safety and efficacy of SakuraBead with shockwave therapy for the treatment of pain secondary to plantar fasciitis. Treatment will be performed on a total of approximately 45 patients who will be followed up for a period of 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arterial Embolisation | Experimental | Temporary embolization using resorbable microspheres |
|
| Shockwave | Active Comparator | Extracorporeal Shockwave Therapy (ESWT); a non-invasive therapeutic approach used to treat a variety of musculoskeletal conditions, including plantar fasciitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial Embolization | Device | Resorbable microspheres are delivered trans-arterially using a microcatheter or introducer sheath to the site of embolization where they will temporarily embolize the hypervascularity in the targeted region with preservation of normal arterial flow. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Compare the proportion of responders between the Investigational procedure and Control. | 3 Months |
| Primary Safety Endpoint | Freedom from device or procedure-related serious adverse events (SAE) following the index procedure (proportions will be compared between Investigational procedure and Control). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Operations Officer | Contact | +1 800 353 4246 | joan.mccabe@crannmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nano Medical Clinic | Recruiting | Tashkent | Uzbekistan | 100095 | Uzbekistan |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D005208 | Fasciitis |
| D005534 | Foot Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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|
| Extracorporeal shockwave therapy | Device | Extracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis. |
|
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |