A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis

NCT07513415 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2026-04-07

No results posted yet for this study

Summary

ENDOVISION Co., Ltd. has developed an intra-articular knee injection with sodium polynucleotide, chitosan, and type I collagen as its main components, and aims to demonstrate the non-inferiority of the investigational device, ALLOHEAL, compared with the control device, Conjuran®, when administered intra-articularly to patients with knee osteoarthritis for the purpose of reducing mechanical friction within the joint cavity.

Conditions

Interventions

DEVICE

ALLOHEAL

ALLOHEAL is an intra-articular injectable filler administered to patients with knee osteoarthritis to improve joint function and reduce pain.

DEVICE

Conjuran

An active comparator administered via intra-articular injection for the treatment of knee osteoarthritis.

Sponsors & Collaborators

  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

    collaborator UNKNOWN
  • National Health Insurance Service Ilsan Hospital

    collaborator OTHER
  • The Catholic University of Korea

    collaborator OTHER
  • Seoul National University Hospital

    collaborator OTHER
  • Chung-Ang University Gwangmyeong Hospital

    collaborator OTHER
  • Ajou University School of Medicine

    collaborator OTHER
  • Konkuk University Medical Center

    collaborator OTHER
  • Bundang CHA General Hospital

    collaborator UNKNOWN
  • Yonsei University Health System, Severance Hospital

    collaborator UNKNOWN
  • Endovision Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-04
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Entities

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 NCT07513415 on ClinicalTrials.gov