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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Rate of subjects with a 50% or more reduction in QuickDASH Score Change
Study Overview
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 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Experimental
If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.
Intervention: Transcatheter Arterial Micro-Embolization (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Rate of VAS Score (patient pain intensity) Change(2~7days,1 month, 3 months, 6 months)
- The rate of reduction of medication(6 months)
- Rate of Changes in symptoms according to in QuickDASH Score(2~7days,1 month, 3 months, 6 months)
- Rate of Changes in symptoms according to the Patient-Rated Tennis Elbow Evaluation (PRTEE) Score(2~7days,1 month, 3 months, 6 months)