Innovative Tool to Analyse Synovial Fluid of Patients With Knee Ostearthritis After IA Injection of Synvisc-one®

NCT04321668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-04-22

No results posted yet for this study

Summary

The objective of this trial is to assess the clinical pertinence of an innovative analytical tool (SYNODIAG) to analyze the Synovial Fluid (SF) composition and guide the patient treatment in a Proof of Concept (PoC) study using OA patients receiving IA injection of SYNVISC ONE®.

Conditions

Interventions

DEVICE

Synvisc-One

SYNVISC-ONE® (Hylan G-F 20), 10 mL single-injection viscosupplement Status : CE marked (CE 0086) class III Medical Device The IP is used according to its usual dosage, administration and indication

Sponsors & Collaborators

  • Artialis

    collaborator INDUSTRY
  • Pulsalys

    lead INDUSTRY

Principal Investigators

  • Jean-Emile Dubuc, MD · Cliniques Universitaires Saint-Luc UCL

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
2020-02-12
Primary Completion
2021-10-01
Completion
2022-02-15

Countries

  • Belgium

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 NCT04321668 on ClinicalTrials.gov