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Recruiting NCT06930677

Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200

No phase Interventional Knee Osteoarthritis (Knee OA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: embolization therapy.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis (Knee OA). Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

Study in patients with knee osteoarthritis treated by embolization using NBGM200

Interventions

  • Device embolization therapy
    MSK embolization

Primary outcome measures

  • Knee Injury and Osteoarthritis Outcome score (KOOS-12) [Time frame: 6 months post treatment]
Secondary outcome measures (2)
  • Visual Analog Scale(VAS) [Time frame: 6 months post treatment]
  • Whole Organ Magnetic Resonance Imaging Score (WORMS) [Time frame: 6 months post treatment]

Eligibility criteria

Inclusion criteria

  • Osteoarthritis proven by MR-imaging

Exclusion criteria

  • Current local infection
  • Life expectancy less than 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 2 centers
  • University Hospital Ghent — Ghent
  • Uz Leuven — Leuven
Netherlands · 1 center
  • Elisabeth-Tweesteden Hospital — Tilburg

Identifiers

NCT: NCT06930677 · TAME 003 · GENTILLE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗