OsteoarthritisNCT06207851
Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist
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
In patients with chronic elbow or wrist pain, the pain is controlled by conventional conservative therapy The pain reduction effect of Nexsphere-F embolization in patients who need additional treatment It is intended to demonstrate safety. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- 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
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2023to 13 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those aged 19 to 80
- Anyone who can provide a consent form
- A person with a life expectancy of at least 12 months
- Those who have not responded or failed in preservation treatment for at least three months(e.g. NSAIDS/physical therapy/steroidal joint injections, etc.)
- VAS score of 4 or higher and moderate-severe elbow or wrist pain
Who cannot join
- Those with a VAS Score of less than 4 and Mild Elbow or Wrist Pain
- Chronic Renal Insufficiency(Serum creatinine > 2mg/dL)
- allergy to iodide contrast agents that do not respond to steroids
- Those with acute infection or malignancy
- Those who have previously had elbow or wrist surgery
- Those with Bleeding Diabetes that cannot be calibrated
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk Hospital
Seoul, Kwang Jin Gu, 120-1
Sang Woo Park, +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 Chronic Pain in Elbow or Wrist
In patients with chronic elbow or wrist pain, the pain is controlled by conventional conservative therapy The pain reduction effect of Nexsphere-F embolization in patients who need additional treatment It is intended to demonstrate safety.
Read the detailed description
This clinical trial is a single cancer, single center, open label, and pilot clinical trial that demonstrates the performance and safety of Nexsphere-F for patients aged 19 to 80 who need additional treatment because their pain is not controlled even after taking existing treatments.
In addition, through this clinical trial, complications of embolization and Nexsphere-F and It checks the safety of side effects. Therefore, in this study, TAME treatment for patients with chronic elbow pain 2 to 7 months, 1 month later, 3 months, 6 wah VAS score reductions and QuickDASH scores, PRTEE score primary 6 Evaluate the reduction rate of medication, discontinuation rate of combination therapy, and occurrence of abnormal cases during the follow-up period. For patients with chronic wrist pain, VAS score after 2 to 7 days, 1 month, 3 months, and 6 months of TAME treatment QuickDASH score reduction rate, drug reduction rate after 6 months, discontinuation rate of combination therapy, and follow-up period the investigators will evaluate the effectiveness and safety of Nexsphere-F by evaluating whether abnormal cases occur during the period.
- 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 |
|---|---|---|
| Experimental | 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 subjects with a 50% or more reduction in QuickDASH Score Change
Descriptive statistics (mean, standard deviation, median, minimum and maximum) are presented for each visit compared to the average change rate baseline of the QuickDASH score before and after clinical trial medical device application.
Measured: 2~7days,1 month, 3 months, 6 months
Secondary outcomes (4)
Rate of VAS Score (patient pain intensity) Change
The rate of change of VAS Score (patient pain intensity)Score before and after application of medical devices for clinical trials.(The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).)
Measured: 2~7days,1 month, 3 months, 6 months
Rate of Changes in symptoms according to in QuickDASH Score
The rate of change of QuickDASH Score before and after application of medical devices for clinical trials.(Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaires. QuickDASH scores range from 0 (no disability) to 100 (most severe disability.))
Measured: 2~7days,1 month, 3 months, 6 months
Rate of Changes in symptoms according to the Patient-Rated Tennis Elbow Evaluation (PRTEE) Score
The rate of change of Patient-Rated Tennis Elbow Evaluation (PRTEE) Score before and after application of medical devices for clinical trials.((Measurements the patient functional status its 15 questionnaires In PRTEE First subscale is The Pain Subscale detail is 5 items Maximum or best score is 0 and worst score is 50 The Second Subscale or PRTEE is The Specific Activities detail is 6 items with finest score is 0 and least score is 60 The third one subscale of PRTEE the Usual Activities sub part 4 items with superior score is 0 and least score is 40. Third Fourth Part of PRTEE is The Function Subscale detail is performance bases specific activities and usual or regular activities Add up to specific or regular activities divided by 2 Maximum best score or prime score is 0 and least score is 50 Total detail Score of PRTEE is = Pain Subscale + Function Subscale Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score).)
Measured: 2~7days,1 month, 3 months, 6 months
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start13 Jul 2023
- Primary completion13 Jul 2026 (estimated)
- Study completion13 Jul 2026 (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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Next Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Woo Park, Principal investigator, Konkuk Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207851
- Sponsor's protocol ID
- NS-F TAME002
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. 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 Chronic Pain in Elbow or Wrist
- ClinicalTrials.gov ID
- NCT06207851
- Acronym / sponsor ID
- NS-F TAME002
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Next Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 13 Jul 2026 (estimated)
- Study completion
- 13 Jul 2026 (estimated)
- First posted
- 17 Jan 2024 (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.
In patients with chronic elbow or wrist pain, the pain is controlled by conventional conservative therapy The pain reduction effect of Nexsphere-F embolization in patients who need additional treatment It is intended to demonstrate safety.
Detailed description
This clinical trial is a single cancer, single center, open label, and pilot clinical trial that demonstrates the performance and safety of Nexsphere-F for patients aged 19 to 80 who need additional treatment because their pain is not controlled even after taking existing treatments.
In addition, through this clinical trial, complications of embolization and Nexsphere-F and It checks the safety of side effects. Therefore, in this study, TAME treatment for patients with chronic elbow pain 2 to 7 months, 1 month later, 3 months, 6 wah VAS score reductions and QuickDASH scores, PRTEE score primary 6 Evaluate the reduction rate of medication, discontinuation rate of combination therapy, and occurrence of abnormal cases during the follow-up period. For patients with chronic wrist pain, VAS score after 2 to 7 days, 1 month, 3 months, and 6 months of TAME treatment QuickDASH score reduction rate, drug reduction rate after 6 months, discontinuation rate of combination therapy, and follow-up period the investigators will evaluate the effectiveness and safety of Nexsphere-F by evaluating whether abnormal cases occur during the period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | 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
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Those aged 19 to 80
- Anyone who can provide a consent form
- A person with a life expectancy of at least 12 months
- Those who have not responded or failed in preservation treatment for at least three months(e.g. NSAIDS/physical therapy/steroidal joint injections, etc.)
- VAS score of 4 or higher and moderate-severe elbow or wrist pain
Key exclusion criteria (6 listed)
- Those with a VAS Score of less than 4 and Mild Elbow or Wrist Pain
- Chronic Renal Insufficiency(Serum creatinine > 2mg/dL)
- allergy to iodide contrast agents that do not respond to steroids
- Those with acute infection or malignancy
- Those who have previously had elbow or wrist surgery
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 | Experimental |
Primary outcome
Rate of subjects with a 50% or more reduction in QuickDASH Score Change
Time frame: 2~7days,1 month, 3 months, 6 months
Descriptive statistics (mean, standard deviation, median, minimum and maximum) are presented for each visit compared to the average change rate baseline of the QuickDASH score before and after clinical trial medical device application.
4 secondary outcomes
Rate of VAS Score (patient pain intensity) Change
Time frame: 2~7days,1 month, 3 months, 6 months
Rate of Changes in symptoms according to in QuickDASH Score
Time frame: 2~7days,1 month, 3 months, 6 months
Rate of Changes in symptoms according to the Patient-Rated Tennis Elbow Evaluation (PRTEE) Score
Time frame: 2~7days,1 month, 3 months, 6 months
The rate of reduction of medication
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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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. This study is not recruiting at the moment.
Sang Woo Park principal investigator
Konkuk 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 6 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Woo Park (+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 subjects with a 50% or more reduction in QuickDASH Score Change (time frame: 2~7days,1 month, 3 months, 6 months). 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 25 Mar 2024.