SakuraBead Used As Resorbable Embolic for Genicular Artery Embolization

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 79 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06550024
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	CrannMed
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Georgia, United States, Uzbekistan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteo Arthritis Knee, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Osteoarthritis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Genicular Artery Embolization (GAE)

Temporary Embolization of Genicular Arteries using Resorbable Microspheres

Active Comparator: Corticosteroid Injection

Corticosteroid injection in the knee

Interventions

Device: - SakuraBead Resorbable Microspheres

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Drug: - Corticosteroid Injection

Corticosteroid injection in the knee

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

IR Centers, Raleigh, North Carolina

Status

Recruiting

Address

IR Centers

Raleigh, North Carolina, 27617

Site Contact

Ari Isaacson, MD

[email protected]

919-883-4601

International Sites

Bokhua Memorial Cardiovascular Center, Tbilisi, Georgia

Status

Not yet recruiting

Address

Bokhua Memorial Cardiovascular Center

Tbilisi, ,

Site Contact

Vakhtang Kipiani, MD

[email protected]

+995 595 76 03 16

Nano Medical Clinic, Tashkent, Uzbekistan

Status

Recruiting

Address

Nano Medical Clinic

Tashkent, , 100095

Site Contact

Sherzod Iskhakov, MD

[email protected]

+998 90 943 4836

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