Clinical Investigation of Sensovisc

NCT ID: NCT07237711

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-25
• Study Completion Date: 2026-11-25

Brief Summary

This clinical investigation aims to investigate the safety and performance of Sensovisc.

Sensovisc is used to reduce osteoarthritis (OA) related pain in the joints by supporting synovial fluid by intra-articular injection and allowing the synovial fluid to restore its viscoelastic properties. It increases the joint mobility by reducing or eliminating the pain.

This Clinical Investigation was designed as a cross-sectional, interventional, and prospective study.

Detailed Description

Osteoarthritis (OA) is the most prevalent chronic arthritis and a leading cause of pain and disability among adults. OA is a degenerative joint disease characterized by chronic inflammation, cartilage degradation and erosion of underlying bone in the affected joints, predominantly affects knees, significantly impacting patient mobility and quality of life.

• Although there are currently no approved disease-modifying osteoarthritis drugs (DMOADs), nonpharmacologic interventions, such as physical therapy and weight management, and pharmaceutical approaches are available to reduce or revise joint damage and inflammation.
• Among various therapeutic interventions, intra-articular hyaluronic acid (HA) injections have emerged as an alternative promising treatment. Emerging evidence suggests that HA may exert chondroprotective effects by enhancing synovial fluid viscosity, improving joint lubrication, and mitigating inflammatory processes, thereby potentially decelerating disease progression and preserving cartilage integrity.

Conditions

Osteo Arthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SV-2-40 or SV-3-60

Patients with a Visual Analogue Scale (VAS) score of 80 mm or higher will receive a single injection of SV-3-60 (Sterile Sodium Hyaluronate Gel-3 mL Prefilled Syringe (2.0%)), whereas those with a score below 80 mm will receive a single injection of SV-2-40 (Sterile Sodium Hyaluronate Gel-2 mL Prefilled Syringe (2.0%) )

Group Type: EXPERIMENTAL

Sensovisc®

Intervention Type: DEVICE

Injectable Sterile Sodium Hyaluronate Gel

SV-2-32

For the patients who will be injected with SV-2-32 (Sterile Sodium Hyaluronate Gel-2 mL Prefilled Syringe (1.6%)), a second injection will be performed 1 week after the first injection.

Group Type: EXPERIMENTAL

Sensovisc®

Intervention Type: DEVICE

Injectable Sterile Sodium Hyaluronate Gel

SV-2-20

3 intra-articular injections of SV-2-20 (Sterile Sodium Hyaluronate Gel-2 mL Prefilled Syringe (1.0%)) administered 1 weeks apart. For the subject in the SV-2-20 group, a second and third injection will be performed one week and two weeks after the first injection.

Group Type: EXPERIMENTAL

Sensovisc®

Intervention Type: DEVICE

Injectable Sterile Sodium Hyaluronate Gel

Interventions

Sensovisc®

Injectable Sterile Sodium Hyaluronate Gel

Intervention Type: DEVICE

Other Intervention Names

Hyaluronic Acid Gel; Intra-articular injection; Sodium Hyaluronate

Eligibility Criteria

Inclusion Criteria

• Patients who have unilateral and/or bilateral knee pain for more than 3 months and meet the diagnosis of osteoarthritis according to ACR criteria
• Diagnosis of Stage II or III knee OA according to the Kellgren and Lawrence (K&L) classification, determined by x-rays taken in the last 12 months
• 40 mm above the pain level determined by VAS during rest for at least 15 days in the month before starting the study (for paracetamol and oral nonsteroidal anti-inflammatory drugs (NSAIDs), taking into account the half-life of the drug)
• Having a Body Mass Index (BMI) ≤ 40 kg/m²,
• Having the mental ability to express pain scores
• Signing the informed consent form indicating consent to participate in the study

Exclusion Criteria

• Radiological K&L stage I and IV
• Acute inflammatory osteoarthritis attack (KOFUS ≥7)
• Septic arthritis
• Secondary OA [Synovial chondromatosis or pigmented villonodular synovitis of the knee, Joint diseases (joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis), Inflammatory diseases (rheumatoid arthritis, gout, infectious arthritis, acute calcium pyrophosphate arthritis)]
• Ipsilateral cruciate or collateral ligament injury in the last 3 months,
• Corticosteroid injection into the target knee within the last 1 month before the first injection
• Hyaluronat injection into the target knee within the last 6 months before the first injection
• Arthroscopy or surgery on the target knee within the last 6 months before the first injection

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

Sponsors

İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi

UNKNOWN

Sponsor Role: collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Emre Adıgüzel

Prof. MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hayriye Şimşek Özgüner

Role: CONTACT

dr.hayriye.simsek@gmail.com

+90 312 552 60 00

Other Identifiers

AnkaraCHBilkentHayriyesimsek02

Identifier Type: -

Identifier Source: org_study_id