Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function

Contrad Swiss

Status: Completed

Conditions: Knee Pain Swelling; Knee Injuries; Knee Arthritis; Pain, Acute; Pain, Chronic; Knee Osteoarthritis

Treatments: Device: AI 500™ SINGLE-DOSE GEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05886608

CTD-SW AI500 2021

Details and patient eligibility

About

Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function

Full description

The aim of this post-market confirmatory interventional clinical investigation is to evaluate the performance and safety of AI500™ SINGLE-DOSE GEL in patients with reduced knee function.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

AI500 single-dose gel

Other group

Description:

Interventional study on AI500 1.5 mL will be topically administered twice: the first at T0 and the second 24h from T0

Treatment:

Device: AI 500™ SINGLE-DOSE GEL