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
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
- Knee Osteoarthritis
- Intra-Articular Injection
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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