EVI-01-IT Safety Study

NCT ID: NCT05422976

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2023-05-31

Brief 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

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EVI-01 treatment

EVI-01 should be injected within the synovial cavity using standard procedures for intra-articular (IA) injections by a physician skilled in performing IA injections.

Group Type: EXPERIMENTAL

EVI-01

Intervention Type: DEVICE

High molecular weight Hyaluronic Acid

Interventions

EVI-01

High molecular weight Hyaluronic Acid

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Eighteen (18) years old or above;
• Patient signed informed consent form;
• Patients with stable symptoms related to knee osteoarthritis for at least 3 months prior to screening;
• Failure, inadequate response or intolerance to analgesics and/or NSAIDs or low-grade opioids;
• Kellgren-Lawrence radiographic stage: II-III diagnosed in the previous 12 months;
• WOMAC average pain index score > 40 mm and < 90 (on a VAS 0-100 mm) on the knee to be treated;
• Difference ≥ 10 mm between the WOMAC average pain score of the knee to be treated and WOMAC average pain score of the contralateral knee at screening;
• Body Mass Index (BMI) inferior to 35 kg/m2 (weight/height).

Exclusion Criteria

• Concomitant inflammatory joint disorder;
• Had received previous visco-supplementation treatment in the study knee within 6 months or intra articular corticosteroids within 3 months* prior to inclusion;
• Infection in or around the study knee;
• Relevant skin disease in the area of injection site;
• Documented presence of injury or trauma of the study knee at screening, including evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments in the study knee;
• History of allergy or intolerance to sodium hyaluronate;
• Documented presence of osteonecrosis in one or both knees;
• Inability to understand the study procedure;
• Participation in another clinical trial within 30 days prior to screening;
• Ongoing therapy with daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment. If dose < 101 mg, it must be maintained during the study;
• Pregnant or breast-feeding at inclusion.

• 1 month = 30 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Donawa Lifescience

UNKNOWN

Sponsor Role: collaborator

Aptissen SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Zaffagnini, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Rizzoli

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Countries

Italy

Other Identifiers

EVI-01-IT

Identifier Type: -

Identifier Source: org_study_id