Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist
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
Next Biomedical Co., Ltd.
38 participants
Jul 13, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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
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Interventions
Participants will undergo TAME with Nexsphere-F.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06207851