OsteoarthritisNCT05917028
Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis
A study testing Transcatheter Arterial Micro-Embolization in people with Osteoarthritis, run by Next Biomedical Co., Ltd. at 1 site in South Korea.
Trial summary
Among knee degenerative osteoarthritis patients aged 50 or older, it will prove the therapeutic effect and safety of Nexsphere-F embolization for patients who need additional treatment because pain is not controlled even if conventional treatments are taken. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Transcatheter Arterial Micro-Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Oct 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria in accordance with ACR guidelines and X-ray findings used within 12 months
- VAS score exceeding 50mm
- An adult male and female over 50 years of age
- Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks
- A person who agrees to maintain existing medication treatments during the clinical trial period but does not receive additional medication or new conservative treatments for knee osteoarthritis pain management.
Who cannot join
- A locally infected patient
- A person whose life expectancy is less than six months
- A person with symptoms of lower extremities that are considered secondary to atherosclerosis or arterial vascular disease (ex: claudication ischemic rest pain)
- A person diagnosed with rheumatism or infectious arthritis
- A person who has undergone knee arthroplasty
- A person who has not had knee microfracture surgery for more than 10 years
Show all 12Show fewer
- INR 2.5 or less than 30,000 platelets
- Anaphylaxis-causing iodine allergy
- Patients with renal dysfunction or impaired renal function who have been diagnosed with less than 45 GFR (eGFR) within the last 60 days
- Those who have a taboo on MR videos
- Pregnant women
- Other cases where it is deemed inappropriate to participate in this clinical trial at the discretion of the researcher
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seodaemun-gu, 03722
Hyuckmin Kwon, +82-32-454-4800, next@nextbiomedical.co.kr
About this study
Official title: A Single Arm, Single Center, Open Label , Pilot Clinical Study to Evaluate the Efficacy and Safety of Transcatheter Arterial Micro Embolization (TAME) Using Nexsphere F in Patients With Knee Degenerative Osteoarthritis
Among knee degenerative osteoarthritis patients aged 50 or older, it will prove the therapeutic effect and safety of Nexsphere-F embolization for patients who need additional treatment because pain is not controlled even if conventional treatments are taken.
Read the detailed description
This clinical trial is a single arm, single center, open label, and pilot clinical trial to prove the performance and safety of Nexsphere-F in patients over the age of 50 who need additional treatment because pain is not controlled even after conventional treatments are taken.
Since consent cannot be obtained during surgery from a subject who meets the inclusion and exclusion criteria, a written consent is obtained in advance between four weeks before the procedure and the day. As one of the usual orthopedic evaluations, baseline MRI will be performed and WORMS will be evaluated. In addition, the WOMAC score and the VAS score will be measured before the procedure and used as a baseline for evaluation variables. Since it is a pilot study to evaluate the validity, all subjects will undergo a Transcatheter Arterial Micro-Embolization (TAME).
- Conditions
- Osteoarthritis
- Being tested
- Transcatheter Arterial Micro-Embolization
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Arterial Micro-EmbolizationDevice
Participants will undergo TAME with Nexsphere-F.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Arterial Micro-Embolization | Experimental | If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F. Receives: Device: Transcatheter Arterial Micro-Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of WOMAC Score Reduction
The rate of change of WOMAC Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.
Measured: 1 day, 14 days, 1 month, 3 months, 6 months
Rate of VAS Score (patient pain intensity) Reduction
The rate of change of VAS Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.
Measured: 1 day, 14 days, 1 month, 3 months, 6 months
Secondary outcomes (3)
Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
The rate of change of WORMS before and after application of medical devices for clinical trials. MRI images of cartilage, marrow abnormality, bone cysts, bone attrition, ostephytes, menisci, ligaments, and synovitis are scored and recorded.
Measured: 1 month
The rate of reduction of medication
The rate of change of medication before and after application of medical devices for clinical trials.
Measured: 6 months
The rate of discontinuation of combination treatment
The rate of change of combination treatment before and after application of medical devices for clinical trials.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start23 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Next Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyuckmin Kwon, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917028
- Sponsor's protocol ID
- NS-F TAME001
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Single Center, Open Label , Pilot Clinical Study to Evaluate the Efficacy and Safety of Transcatheter Arterial Micro Embolization (TAME) Using Nexsphere F in Patients With Knee Degenerative Osteoarthritis
- ClinicalTrials.gov ID
- NCT05917028
- Acronym / sponsor ID
- NS-F TAME001
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Next Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among knee degenerative osteoarthritis patients aged 50 or older, it will prove the therapeutic effect and safety of Nexsphere-F embolization for patients who need additional treatment because pain is not controlled even if conventional treatments are taken.
Detailed description
This clinical trial is a single arm, single center, open label, and pilot clinical trial to prove the performance and safety of Nexsphere-F in patients over the age of 50 who need additional treatment because pain is not controlled even after conventional treatments are taken.
Since consent cannot be obtained during surgery from a subject who meets the inclusion and exclusion criteria, a written consent is obtained in advance between four weeks before the procedure and the day. As one of the usual orthopedic evaluations, baseline MRI will be performed and WORMS will be evaluated. In addition, the WOMAC score and the VAS score will be measured before the procedure and used as a baseline for evaluation variables. Since it is a pilot study to evaluate the validity, all subjects will undergo a Transcatheter Arterial Micro-Embolization (TAME).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Arterial Micro-Embolization | Experimental | Device: Transcatheter Arterial Micro-EmbolizationIf abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria in accordance with ACR guidelines and X-ray findings used within 12 months
- VAS score exceeding 50mm
- An adult male and female over 50 years of age
- Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks
- A person who agrees to maintain existing medication treatments during the clinical trial period but does not receive additional medication or new conservative treatments for knee osteoarthritis pain management.
Key exclusion criteria (12 listed)
- A locally infected patient
- A person whose life expectancy is less than six months
- A person with symptoms of lower extremities that are considered secondary to atherosclerosis or arterial vascular disease (ex: claudication ischemic rest pain)
- A person diagnosed with rheumatism or infectious arthritis
- A person who has undergone knee arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Arterial Micro-EmbolizationParticipants will undergo TAME with Nexsphere-F. | Device | Transcatheter Arterial Micro-Embolization |
Primary outcome
Rate of WOMAC Score Reduction
Time frame: 1 day, 14 days, 1 month, 3 months, 6 months
The rate of change of WOMAC Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.
Rate of VAS Score (patient pain intensity) Reduction
Time frame: 1 day, 14 days, 1 month, 3 months, 6 months
The rate of change of VAS Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.
3 secondary outcomes
Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Time frame: 1 month
The rate of reduction of medication
Time frame: 6 months
The rate of discontinuation of combination treatment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyuckmin Kwon principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Arterial Micro-Embolization in people with Osteoarthritis, run by Next Biomedical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyuckmin Kwon (+82-32-454-4800, next@nextbiomedical.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of WOMAC Score Reduction (time frame: 1 day, 14 days, 1 month, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.