Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis (Knee OA)

• Registration Number: NCT06930677
• Lead Sponsor: Next Biomedical Co., Ltd.

Brief Summary

Study in patients with knee osteoarthritis treated by embolization using NBGM200

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-16
• Study Start: 2025-04-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Osteoarthritis proven by MR-imaging

Exclusion Criteria

• Current local infection
• Life expectancy less than 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome score (KOOS-12)	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 Outcome Measures

Name	Time	Method
Visual Analog Scale(VAS)	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
Whole Organ Magnetic Resonance Imaging Score (WORMS)	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.

Trial Locations

Locations (3)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Uz Leuven; 🇧🇪 Leuven, Belgium

Elisabeth-Tweesteden Hospital; 🇳🇱 Tilburg, Netherlands