EVI-01-IT Safety Study
NCT05422976 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2023-07-21
Summary
Prospective, single arm, pilot study to assess the safety and tolerability of a single intra-articular injection of EVI-01 for the treatment of symptomatic knee osteoarthritis.
Conditions
Interventions
- DEVICE
-
EVI-01
High molecular weight Hyaluronic Acid
Sponsors & Collaborators
-
Donawa Lifescience
collaborator UNKNOWN -
Aptissen SA
lead INDUSTRY
Principal Investigators
-
Stefano Zaffagnini, MD · IRCCS Istituto Ortopedico Rizzoli
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-23
- Primary Completion
- 2023-05-31
- Completion
- 2023-05-31
Countries
- Italy
Study Locations
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