Clinical trial NCT05886608: Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Pain, Chronic
Knee Injuries
Knee Osteoarthritis
Knee Arthritis
Knee Pain Swelling
Keywords: Knee
Pain
Hyaluronic Acid
Peptides
Non-invasive
Lead sponsor: Contrad Swiss SA
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week
timeFrame: 1 Week
Secondary outcomes:
measure: Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 48 hours
timeFrame: 2 days
measure: Clinical performance of AI500™ SINGLE DOSE GEL in alleviating pain after 24h and 48h of treatment.
timeFrame: 2 days
measure: Safety and Tolerability of AI500™ SINGLE DOSE GEL
timeFrame: 1 week
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milano
Study officials:
References: