Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain

NCT ID: NCT06872567

Last Updated: 2025-11-24

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

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-12-31

Brief Summary

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Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection

Detailed Description

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Conditions

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Knee Osteoarthritis (Knee OA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Corticosteroid Injection

Intervention Type DRUG

Corticosteroid Injection

Device: GAE

Group Type EXPERIMENTAL

genicular artery embolization

Intervention Type DEVICE

genicular artery embolization

Interventions

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genicular artery embolization

genicular artery embolization

Intervention Type DEVICE

Corticosteroid Injection

Corticosteroid Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient has localized knee pain
* Must be an appropriate candidate for arterial vascular access procedure

Exclusion Criteria

* Known sensitivity or allergy to implant materials
* Unable or unwilling to comply with study requirements
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Next Biomedical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

North American Science Associates Ltd.

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ziv J Haskal, MD

Role: CONTACT

16463691570

Other Identifiers

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US037031

Identifier Type: -

Identifier Source: org_study_id

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