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

NCT ID: NCT06718478

Last Updated: 2024-12-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2024-08-23

Brief Summary

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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

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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.

Conditions

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Osteoarthritis (OA) of the Knee Osteoarthritis Knee Pain Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Arthritis Osteoarthritis

Keywords

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Genicular Artery Embolization GAE Knee Embolization Knee OA Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Genicular Artery Embolization (GAE)

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Group Type EXPERIMENTAL

SakuraBead Resorbable Microspheres

Intervention Type DEVICE

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Interventions

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SakuraBead Resorbable Microspheres

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

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

Tashkent, , Uzbekistan

Site Status

Countries

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Uzbekistan

Other Identifiers

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CI520

Identifier Type: -

Identifier Source: org_study_id