Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function
NCT ID: NCT05886608
Last Updated: 2023-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-08-30
2023-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AI500 single-dose gel
Interventional study on AI500 1.5 mL will be topically administered twice: the first at T0 and the second 24h from T0
AI 500™ SINGLE-DOSE GEL
AI500™ SINGLE-DOSE GEL is a hydrogel to be applied to intact skin, intended to provide relief in cases of pain due to tension in muscles and adjacent tissues, to improve movement and function.
Interventions
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AI 500™ SINGLE-DOSE GEL
AI500™ SINGLE-DOSE GEL is a hydrogel to be applied to intact skin, intended to provide relief in cases of pain due to tension in muscles and adjacent tissues, to improve movement and function.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Contrad Swiss SA
INDUSTRY
Responsible Party
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Locations
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Humanitas Research Hospital
Rozzano, Milano, Italy
Countries
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Other Identifiers
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CTD-SW AI500 2021
Identifier Type: -
Identifier Source: org_study_id
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