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ArtiAid® for Knee Osteoarthritis: A Post-market Study

NCT05881330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-05-31

No results posted yet for this study

Summary

The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:

* the safety profile of ArtiAid®;
* the clinical performance of ArtiAid®, such as pain relief and satisfaction of treatment.

Participants will receive weekly injections of ArtiAid® for 5 weeks and be follow-up for 26 weeks.

Conditions

  • Hyaluronic Acid

Interventions

DEVICE

ArtiAid Intra-articular Injection

Inject ArtiAid® in the affected joint at weekly interval for 5 weeks.

Sponsors & Collaborators

  • Maxigen Biotech Inc.

    lead INDUSTRY

Principal Investigators

  • Tsu-Te Yeh, Doctor · Tri-Service General Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-09-22
Completion
2022-11-25

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05881330 on ClinicalTrials.gov