Trials / Recruiting
RecruitingNCT05917028
Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Next Biomedical Co., Ltd. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This clinical trial is a single arm, single center, open label, and pilot clinical trial to prove the performance and safety of Nexsphere-F in patients over the age of 50 who need additional treatment because pain is not controlled even after conventional treatments are taken. Since consent cannot be obtained during surgery from a subject who meets the inclusion and exclusion criteria, a written consent is obtained in advance between four weeks before the procedure and the day. As one of the usual orthopedic evaluations, baseline MRI will be performed and WORMS will be evaluated. In addition, the WOMAC score and the VAS score will be measured before the procedure and used as a baseline for evaluation variables. Since it is a pilot study to evaluate the validity, all subjects will undergo a Transcatheter Arterial Micro-Embolization (TAME).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Arterial Micro-Embolization | Participants will undergo TAME with Nexsphere-F. |
Timeline
- Start date
- 2023-10-23
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2023-06-23
- Last updated
- 2025-04-02
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05917028. Inclusion in this directory is not an endorsement.