SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

NCT ID: NCT06550024

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-28

Study Completion Date

2027-04-30

Brief Summary

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

Detailed Description

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To compare safety and efficacy of SakuraBead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on a total of approximately 89 patients who will be followed up for a period of 2 years.

Conditions

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Osteo Arthritis Knee Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Arthritis Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Genicular Artery Embolization (GAE)

Temporary Embolization of Genicular Arteries using Resorbable Microspheres

Group Type EXPERIMENTAL

SakuraBead Resorbable Microspheres

Intervention Type DEVICE

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Corticosteroid Injection

Corticosteroid injection in the knee

Group Type ACTIVE_COMPARATOR

Corticosteroid Injection

Intervention Type DRUG

Corticosteroid injection in the knee

Interventions

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SakuraBead Resorbable Microspheres

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Intervention Type DEVICE

Corticosteroid Injection

Corticosteroid injection in the knee

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subject is able and willing to provide written informed consent, and
2. Clinical diagnosis of knee OA, and
3. Moderate to severe knee pain (WOMAC Pain ≥ 10), and
4. Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
6. Age ≥ 40 years and \< 80 years, and
7. Able to comply with all treatments and follow-up visits.

Exclusion Criteria

1. Severe knee OA (Kellgren-Lawrence grade 4), or
2. Current infection of target joint, or
3. Life expectancy less than 36 months, or
4. Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
6. Prior knee replacement surgery in the target knee, or
7. Pain score of \>3 NRS on the non-target knee, or
8. An acute internal derangement of the target knee, or
9. History of uncorrectable coagulopathy, or
10. Prior iodinated contrast reaction resulting in anaphylaxis, or
11. Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
12. Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or
13. Contraindication to MRI, or
14. At the discretion of the Principal Investigator
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CrannMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama Medicine

Birmingham, Alabama, United States

Site Status RECRUITING

Harbor UCLA Medical Center

Torrance, California, United States

Site Status RECRUITING

Advanced Vascular Institute

Panama City, Florida, United States

Site Status RECRUITING

IR Centers

Raleigh, North Carolina, United States

Site Status RECRUITING

Orthopedic and Fracture Specialists (O&FS)

Portland, Oregon, United States

Site Status WITHDRAWN

IR Centers

Leesburg, Virginia, United States

Site Status RECRUITING

Bokhua Memorial Cardiovascular Center

Tbilisi, , Georgia

Site Status RECRUITING

Royal Berkshire NHS Foundation Trust

Reading, , United Kingdom

Site Status RECRUITING

Nano Medical Clinic

Tashkent, Uzbekistan, Uzbekistan

Site Status RECRUITING

Countries

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United States Georgia United Kingdom Uzbekistan

Central Contacts

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Chief Operations Officer

Role: CONTACT

+1 800 353 4246

Facility Contacts

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Evan Hudson, MAEd, BS, CHES

Role: primary

205-934-6499

Study Coordinator

Role: primary

323-457-1647

Johnna Smith Sanders

Role: primary

+1 (850) 628-9177

Ari Isaacson, MD

Role: primary

919-883-4601

Sindhu Reddy

Role: primary

+1 732-783-1259

Vakhtang Kipiani, MD

Role: primary

+995 595 76 03 16

Study Coordinator

Role: primary

+44 (0)118 322 5703

Sherzod Iskhakov, MD

Role: primary

+998 90 943 4836

Other Identifiers

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CI570

Identifier Type: -

Identifier Source: org_study_id

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