Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist

N

Nextbiomedical

Status

Enrolling

Conditions

Osteoarthritis

Treatments

Device: Transcatheter Arterial Micro-Embolization

Study type

Interventional

Funder types

Industry

Identifiers

NCT06207851
NS-F TAME002

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Experimental
Experimental group
Description:
If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.
Treatment:
Device: Transcatheter Arterial Micro-Embolization

Trial contacts and locations

1

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Central trial contact

Jin Ho Hwang; Sang Woo Park

Data sourced from clinicaltrials.gov

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