Clinical trial NCT06207851: Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Next Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Rate of subjects with a 50% or more reduction in QuickDASH Score Change
timeFrame: 2~7days,1 month, 3 months, 6 months
Secondary outcomes:
measure: Rate of VAS Score (patient pain intensity) Change
timeFrame: 2~7days,1 month, 3 months, 6 months
measure: Rate of Changes in symptoms according to in QuickDASH Score
timeFrame: 2~7days,1 month, 3 months, 6 months
measure: Rate of Changes in symptoms according to the Patient-Rated Tennis Elbow Evaluation (PRTEE) Score
timeFrame: 2~7days,1 month, 3 months, 6 months
measure: The rate of reduction of medication
timeFrame: 6 months
Other outcomes:
measure: Number of participants with abnormal cases during follow-up
timeFrame: 1day ,2~7days,1 month, 3 months, 6 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk Hospital
state: Kwang Jin Gu
Study officials:
affiliation: Konkuk Hospital
name: Sang Woo Park
role: PRINCIPAL_INVESTIGATOR
References: