Clinical trial NCT06718478: First in Human Study of SakuraBead for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteoarthritis
Official title: First in Human Study of SakuraBead for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Osteoarthritis Knee Pain
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Arthritis
Osteoarthritis
Keywords: Genicular Artery Embolization
GAE
Knee Embolization
Knee OA
Knee Osteoarthritis
Lead sponsor: CrannMed
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single-centre, single-arm, unmasked, First in Human study that aims to evaluate the safety and efficacy of SakuraBead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis.

Detailed description: To evaluate safety and efficacy of SakuraBead for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on up to 15 patients who will be followed up for a period of 6 months.

Eligibility criteria: Inclusion Criteria:

1. Patient is able and willing to provide written informed consent, and
2. Clinical diagnosis of knee OA, and
3. Moderate to severe knee pain (VAS ≥ 5), and
4. Pain refractory to at least 3 months\* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and
5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
6. Age 40 years or older.
7. Subject has confirmed evidence of knee OA, defined as an angiographic 'blush' pattern (radiographic) in one or more of the target genicular artery(ies).

Exclusion Criteria:

1. Severe knee OA (Kellgren-Lawrence grade 4)
2. Current infection of target joint, or
3. Life expectancy less than 24 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. Complete meniscal or cruciate tear that requires surgery, or
8. History of uncorrectable coagulopathy, or
9. Prior iodinated contrast reaction resulting in anaphylaxis, or
10. Pregnant and/or lactating female, or
11. At the discretion of the Principal Investigator
12. Subject has evidence of arterial occlusion precluding catheterization.
13. Subject has occlusion of the genicular arteries.

Primary outcomes:
measure: Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up.
timeFrame: 1 month
measure: Genicular Artery Embolization (GAE) without a major device- or procedure-related complication at 1 month follow-up
timeFrame: 1 month
Secondary outcomes:
measure: Reduction in global Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire at 1 month, 3 months and 6 months follow-up
timeFrame: 1, 3 and 6 months
measure: Reduction of previously initiated OsteoArthritis (OA) medical therapy at 3- and 6-months follow-up
timeFrame: 3 and 6 months
measure: Decrease of pain on Visual Analogue Scale (VAS) at 3 and 6 months
timeFrame: 3 and 6 months
measure: No major device- or procedure-related complication at 3 and 6 months
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: The Republican Specialized Scientific and Practical Medical Center of Therapy and Medical Rehabilitation
Study officials:
References: