Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function
CompletedNot applicableNCT05886608
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function
Study details
- Official title
- Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function: a Post-market Confirmatory Interventional, Single Arm Clinical Investigation
- Conditions
- Pain, Acute
- Pain, Chronic
- Knee Injuries
- Knee Osteoarthritis
- Knee Arthritis
- Knee Pain Swelling
- Interventions
- Device: AI 500™ SINGLE-DOSE GEL
- Sponsor
- Contrad Swiss SA
- Start date
- 2022-08-30
- Primary completion
- 2023-03-16
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Signed patient informed consent form (ICF). 2. Male or Female aged ≥ 18 years at the time of the signature of ICF. 3. Presenting with reduced knee function caused by osteoarthritis flare-ups, meniscal injuries, ligament injuries, inflammation of soft tissues, assessed as 20-45 rating according to the WOMAC function scale. 4. Willingness to follow all study procedures, including attending all site visits, tests, and examinations. 5. Willingness to follow indications. Exclusion Criteria: 1. Use of analgesics within the 24 hours prior to V0. 2. Damaged, infected, or ulcerated skin in the area of treatment. 3. Ongoing cutaneous allergies. 4. Serious and chronic pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) or lesions including cancer with/without ongoing antitumor therapy. 5. Patients suffering from muscular dystrophy. 6. Patients presenting with bone fractures or severe injuries (including locked knee). 7. Severely disabled arthritic patients using a wheelchair. 8. Allergy to device components (Sodium hyaluronate; SHPolypeptide- 6; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; PEG-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA). 9. Immune system illnesses. 10. Uncontrolled systemic diseases. 11. Known drug and/or alcohol abuse. 12. Mental incapacity that precludes adequate understanding or cooperation. 13. Participation in another investigational study. 14. Pregnancy or breastfeeding. 15. Patients with both knees affected/damaged.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05886608