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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Konkuk Hospital
RECRUITING
Seoul
Contact Information
Primary
Sang Woo Park
next@nextbiomedical.co.kr
+82-32-454-4800
Backup
Jin Ho Hwang
next@nextbiomedical.co.kr
+82-32-454-4800
Time Frame
Start Date: 2023-07-13
Estimated Completion Date: 2026-07-13
Participants
Target number of participants: 38
Treatments
Experimental: Experimental
If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.
Related Therapeutic Areas
Sponsors
Leads: Next Biomedical Co., Ltd.