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Recruiting

NCT Number: NCT06930677

Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200

Study in patients with knee osteoarthritis treated by embolization using NBGM200

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Osteoarthritis proven by MR-imaging

Exclusion criteria

  • Current local infection
  • Life expectancy less than 6 months

Treatment and study plan

embolization therapy

Device

MSK embolization

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome score (KOOS-12)

    Time frame: 6 months post treatment

    Knee Injury and Osteoarthritis Outcome score (KOOS-12) is to evaluate the pain, function and quality of life. The total score ranges from 0 to 100, where higher scores indicate better outcomes.

Secondary outcomes

  1. Visual Analog Scale(VAS)

    Time frame: 6 months post treatment

    Visual Analog Scale(VAS) is to evaluate the pain from 0 to 10. Higher scores indicate worse outcomes, representing more severe pain

  2. Whole Organ Magnetic Resonance Imaging Score (WORMS)

    Time frame: 6 months post treatment

    Whole Organ Magnetic Resonance Imaging Score (WORMS) is a semi-quantitative scoring method for multi-feature, whole-organ evaluation of knee OA based on MRI. The total score ranges from 0 to 332, with higher scores indicating worse outcomes.

Sponsors and collaborators

Lead sponsor

Next Biomedical Co., Ltd.

Industry

Registry information

Official study title

A Prospective, Single-arm, Multinational, Multi-center, Clinical Study to Evaluate the Performance and Safety of Musculoskeletal Embolization Using NBGM200 in Patients With Knee Degenerative Osteoarthritis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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