Embolization treatment for knee osteoarthritis
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
This study is testing a new treatment called embolization therapy to see if it can help people with knee osteoarthritis feel less pain and move better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Next Biomedical Co., Ltd. Industry-sponsored |
| Locations | 3 sites (Ghent and 2 other locations) |
| Trial ID | NCT06930677 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of embolization therapy using NBGM200 in patients diagnosed with knee osteoarthritis. The approach involves targeting the affected area to potentially alleviate pain and improve function. Patients will be selected based on MR-imaging confirmation of osteoarthritis, while those with local infections or limited life expectancy will be excluded. The study aims to evaluate the safety and efficacy of this novel treatment method.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with knee osteoarthritis confirmed by MR-imaging.
Not a fit: Patients with current local infections or a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved mobility for patients suffering from knee osteoarthritis.
How similar studies have performed: While embolization therapy is a novel approach for knee osteoarthritis, similar studies in other conditions have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Osteoarthritis proven by MR-imaging Exclusion Criteria: * Current local infection * Life expectancy less than 6 months
Where this trial is running
Ghent and 2 other locations
- University Hospital Ghent — Ghent, Belgium (Recruiting)
- Uz Leuven — Leuven, Belgium (Recruiting)
- Elisabeth-Tweesteden Hospital — Tilburg, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.