Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate… (NCT06422169) | Clinical Trial Compass
RecruitingNot Applicable
Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain
Italy35 participantsStarted 2024-05-08
Plain-language summary
Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain
Who can participate
Age range18 Years – 84 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient (males and females) aged between 18 and 84 years (limits included);
* Patient able to understand the nature and purpose of the study, including possible risks and side effects;
* Patient able to provide written Informed Consent, in accordance with good clinical practice and current legislation;
* Pain ≥ 40 mm on the VAS score in the target knee for at least 2 months;
* Patient with knee osteoarthritis assessed radiographically, grade 1 to 3 according to the Kellgren-Lawrence scale (K-L);
* Body Mass Index (BMI) ≤ 35;
* Patient who will benefit from this treatment;
* Patient available for the entire study period;
* Patient able to cooperate and meet the requirements of the clinical investigation plan.
Exclusion Criteria:
* Patient with knee osteoarthritis, assessed radiographically, grade 4 by the K-L scale;
* Patient presenting ongoing inflammation/infection at the level of the joint being investigated;
* Patient with abundant intra-articular effusion;
* Patient with symptoms of viral or bacterial infections or similar;
* Patient with insertion point of the joint infected or in the presence of a skin disease;
* Simultaneous treatment with disinfectants containing quaternary ammonium salts or chlorhexidine;
* Patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device;
* Concomitant treatments with thrombolytic or anticoagulant therapies, for less than 2 weeks p…
What they're measuring
1
Reduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline