Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Kn… (NCT05886608) | Clinical Trial Compass
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a product called the AI500™ Single-Dose Gel injected into the knee — can you explain what this gel is, how it works, and whether it's something that might be relevant to my specific type of knee problem?
2The trial is listed as completed but was Phase NA, which sometimes means it was evaluating a medical device rather than a drug — does that affect how much we can trust the safety and effectiveness data from it, and where can we find those results?
3The main thing this trial measured was improvement in knee function after just one week — does a one-week timeframe tell us enough about whether this kind of treatment would help my knee pain over the longer term?
4Given that this trial covered a range of conditions from acute pain to chronic osteoarthritis, how do you know if the results would apply to someone with my specific diagnosis, and do you think I'm more of an acute or chronic case?
5Are there standard, well-established treatments for my knee condition that I should consider before looking into something like this gel, or does this kind of single-dose injection fit naturally into a treatment plan you'd recommend for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week