First in Human Study of SakuraBead for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteoarthritis

NCT06718478 | Completed

• 1 other identifier: CI520
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up.

  1 month

• Genicular Artery Embolization (GAE) without a major device- or procedure-related complication at 1 month follow-up

  1 month

Secondary Outcomes (4)

• Reduction in global Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire at 1 month, 3 months and 6 months follow-up

  1, 3 and 6 months

• Reduction of previously initiated OsteoArthritis (OA) medical therapy at 3- and 6-months follow-up

  3 and 6 months

• Decrease of pain on Visual Analogue Scale (VAS) at 3 and 6 months

  3 and 6 months

• No major device- or procedure-related complication at 3 and 6 months

  3 and 6 months

Study Arms (1)

Genicular Artery Embolization (GAE)

EXPERIMENTAL

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Device: SakuraBead Resorbable Microspheres

Interventions

SakuraBead Resorbable Microspheres DEVICE

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Genicular Artery Embolization (GAE)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe knee OA (Kellgren-Lawrence grade 4)
• Current infection of target joint, or
• Life expectancy less than 24 months, or
• 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
• Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
• Prior knee replacement surgery in the target knee, or
• Complete meniscal or cruciate tear that requires surgery, or
• History of uncorrectable coagulopathy, or
• Prior iodinated contrast reaction resulting in anaphylaxis, or
• Pregnant and/or lactating female, or
• At the discretion of the Principal Investigator
• Subject has evidence of arterial occlusion precluding catheterization.
• Subject has occlusion of the genicular arteries.

Sponsors & Collaborators

• CrannMed: lead

Study Sites (1)

The Republican Specialized Scientific and Practical Medical Center of Therapy and Medical Rehabilitation

Tashkent, Uzbekistan

Location

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 5, 2023
• Primary Completion: March 28, 2024
• Study Completion: August 23, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)