Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200

November 17, 2025 updated by: Next Biomedical Co., Ltd.

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

Study in patients with knee osteoarthritis treated by embolization using NBGM200

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • Recruiting
        • University Hospital Ghent
        • Contact:
          • University Hospital Ghent
          • Phone Number: 09 332 21 11
        • Principal Investigator:
          • Elisabeth Dhondt
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven
        • Contact:
          • UZ LEUVEN
          • Phone Number: +32 16 33 22 11
  • Netherlands
      • Tilburg, Netherlands
        • Recruiting
        • Elisabeth-TweeSteden Hospital
        • Contact:
          • Paul N. M. Lohle
          • Phone Number: +31 13 221 0000
          • Email: p.lohle@etz.nl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Osteoarthritis proven by MR-imaging

Exclusion Criteria:

  • Current local infection
  • Life expectancy less than 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSK embolization
Device: embolization therapy
MSK embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months post treatment
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.
6 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Next Biomedical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAME 003
  • GENTILLE (Other Identifier: Elisabeth-Tweesteden Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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