SakuraBead Used as Resorbable Embolic for Plantar Fascia Embolization
NCT07241884 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2025-11-21
Summary
This is a prospective, single center, double arm, randomized, unmasked, First in Human study that aims to evaluate the safety and effectiveness of SakuraBead™ resorbable embolization microspheres in adult patients suffering from pain secondary to plantar fasciitis.
Conditions
- Plantar Fascitis
- Heel Pain
- Musculoskeletal Diseases
Interventions
- DEVICE
-
Arterial Embolization
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.
- DEVICE
-
Extracorporeal shockwave therapy
Extracorporeal shockwave therapy (ESWT) is a treatment using acoustic pulses to treat plantar fasciitis.
Sponsors & Collaborators
-
CrannMed
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-20
- Primary Completion
- 2026-06-30
- Completion
- 2027-03-31
Countries
- Uzbekistan
Study Locations
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