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To Evaluate the Performance and Safety of the Medical Device IRADYN in Subjects With Osteoarthritis of the Knee

NCT05206474 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-03-15

No results posted yet for this study

Summary

The benefits of single or repetitive administration (1 to 6) can have similar result in terms of muscular strength and patients' quality of life improvement, benefiting of the advantages of polymerized polynucleotides (IRADYN) formulation.

Conditions

Interventions

DEVICE

IRADYN

One course of IRADYN® at baseline, consisting of a mono-dose intra-articular administration (2 ml). From week 1 to week 6, injection will be performed, if necessary, during the visit, following the dosage reported in the instruction for use / summary of product characteristic.

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • I.R.A. Istituto Ricerche Applicate S.p.A.

    lead NETWORK

Principal Investigators

  • George Puenea, MD · Fizio Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2022-08-01
Completion
2022-10-01

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

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 NCT05206474 on ClinicalTrials.gov