Nexsphere-F treatment for chronic elbow or wrist pain
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
This study is testing a new treatment called Nexsphere-F to see if it can help people aged 19 to 80 with chronic elbow or wrist pain who haven't found relief from regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Next Biomedical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Kwang Jin Gu) |
| Trial ID | NCT06207851 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of Transcatheter Arterial Micro-Embolization (TAME) using Nexsphere-F in patients aged 19 to 80 who suffer from chronic pain in the elbow or wrist. Participants must have experienced inadequate relief from conventional treatments for at least three months and have a moderate to severe pain level. The study will assess pain reduction and safety through various scoring methods over a follow-up period of six months. It aims to provide an alternative treatment option for those who have not responded to standard therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 80 with moderate to severe chronic elbow or wrist pain who have not responded to conservative treatments.
Not a fit: Patients with mild pain (VAS score less than 4) or those with chronic renal insufficiency or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer significant pain relief for patients with chronic elbow or wrist pain who have not benefited from existing therapies.
How similar studies have performed: While this approach is relatively novel, similar embolization techniques have shown promise in other pain management studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Those aged 19 to 80 2. Anyone who can provide a consent form 3. A person with a life expectancy of at least 12 months 4. Those who have not responded or failed in preservation treatment for at least three months(e.g. NSAIDS/physical therapy/steroidal joint injections, etc.) 5. VAS score of 4 or higher and moderate-severe elbow or wrist pain Exclusion Criteria: 1. Those with a VAS Score of less than 4 and Mild Elbow or Wrist Pain 2. Chronic Renal Insufficiency(Serum creatinine \> 2mg/dL) 3. allergy to iodide contrast agents that do not respond to steroids 4. Those with acute infection or malignancy 5. Those who have previously had elbow or wrist surgery 6. Those with Bleeding Diabetes that cannot be calibrated
Where this trial is running
Seoul, Kwang Jin Gu
- Konkuk Hospital — Seoul, Kwang Jin Gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Sang Woo Park — Konkuk Hospital
- Study coordinator: Sang Woo Park
- Email: next@nextbiomedical.co.kr
- Phone: +82-32-454-4800
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.