ArtiAid® Plus for Knee Osteoarthritis: A Post-market Study
NCT05881317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2023-05-31
Summary
The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Plus Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:
* the safety profile of ArtiAid® Plus;
* the clinical performance of ArtiAid® Plus, such as pain relief and satisfaction of treatment.
Participants will receive weekly injections of ArtiAid® Plus for 3 weeks and be follow-up for 26 weeks.
Conditions
- Hyaluronic Acid
Interventions
- DEVICE
-
ArtiAid® Plus Intra-articular Injection
Inject ArtiAid® Plus in the affected joint at weekly interval for 3 weeks
Sponsors & Collaborators
-
Maxigen Biotech Inc.
lead INDUSTRY
Principal Investigators
-
Cheng Fong Chen · Taipei Veterans General Hospital, Taiwan
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-02
- Primary Completion
- 2022-06-06
- Completion
- 2022-11-21
Countries
- Taiwan
Study Locations
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