CompletedNot Applicable

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

Italy35 participantsStarted 2022-08-30

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed patient informed consent form (ICF).
✓. Male or Female aged ≥ 18 years at the time of the signature of ICF.
✓. 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.
✓. Willingness to follow all study procedures, including attending all site visits, tests, and examinations.
✓. Willingness to follow indications.

✕. Use of analgesics within the 24 hours prior to V0.
✕. Damaged, infected, or ulcerated skin in the area of treatment.
✕. Ongoing cutaneous allergies.
✕. Serious and chronic pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) or lesions including cancer with/without ongoing antitumor therapy.
✕. Patients suffering from muscular dystrophy.
✕. Patients presenting with bone fractures or severe injuries (including locked knee).
✕. Severely disabled arthritic patients using a wheelchair.
✕. 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).

Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week

Timeframe: 1 Week

NCT IDNCT05886608

SponsorContrad Swiss SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-16

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed patient informed consent form (ICF).
✓. Male or Female aged ≥ 18 years at the time of the signature of ICF.
✓. 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.
✓. Willingness to follow all study procedures, including attending all site visits, tests, and examinations.
✓. Willingness to follow indications.

✕. Use of analgesics within the 24 hours prior to V0.
✕. Damaged, infected, or ulcerated skin in the area of treatment.
✕. Ongoing cutaneous allergies.
✕. Serious and chronic pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) or lesions including cancer with/without ongoing antitumor therapy.
✕. Patients suffering from muscular dystrophy.
✕. Patients presenting with bone fractures or severe injuries (including locked knee).
✕. Severely disabled arthritic patients using a wheelchair.
✕. 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).