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 Knee Degenerative Osteoarthritis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Among knee degenerative osteoarthritis patients aged 50 or older, it will prove the therapeutic effect and safety of Nexsphere-F embolization for patients who need additional treatment because pain is not controlled even if conventional treatments are taken.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria in accordance with ACR guidelines and X-ray findings used within 12 months

• VAS score exceeding 50mm

• An adult male and female over 50 years of age

• Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks

• A person who agrees to maintain existing medication treatments during the clinical trial period but does not receive additional medication or new conservative treatments for knee osteoarthritis pain management.

Locations
Other Locations
Republic of Korea
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Hyuckmin Kwon
next@nextbiomedical.co.kr
+82-32-454-4800
Backup
Sungmo Moon
next@nextbiomedical.co.kr
+82-32-454-4800
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
Experimental: Transcatheter Arterial Micro-Embolization
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.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials