Status:
RECRUITING
Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist
Lead Sponsor:
Next Biomedical Co., Ltd.
Conditions:
Osteoarthritis
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief 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 treatmen...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 13 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06207851
Start Date
July 13 2023
End Date
July 13 2026
Last Update
March 25 2024
Active Locations (1)
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1
Konkuk Hospital
Seoul, Kwang Jin Gu, South Korea, 120-1