NCT06422169招募中不适用
Interventistic Monocentric Pre-market Clinical Investigation on the Use of Medical Device "ArToFILL" in Subjects With Mild-moderate Osteoarticular Pain
PromoPharma spa1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Reduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline
研究概览
简要总结
Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain
详细描述
Monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of ArToFILL for the treatment of mild-moderate osteoarticular pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 prior to the screening visit;
- •Intra-articular treatments carried out in the last 3 months (9 months if with products containing hyaluronic acid) of the target joint;
- •Topical treatments of the target joint in progress or performed within 1 week of the screening visit;
- •Taking NSAIDs and/or paracetamol as rescue treatment for more than two consecutive days;
- •Surgical interventions of prosthetic replacement in the target joint;
- •Physiotherapy and instrumental physical therapy treatments for the target joint performed in the last 2 weeks prior to the screening visit, and during the study period;
- •Participation in another clinical trial within 60 days prior to the screening visit;
- •Evidence of severe or uncontrolled systemic disease or any other significant disorder (e.g. haemophilia, bleeding disorders etc.); which do not allow participation in the study or could compromise the results.
- •Patients who are pregnant or breastfeeding;
- •Subject unable to follow clinical investigation procedures and follow-up visits;
- •Any other medical condition which could influence participation in the clinical investigation or compromise its results.
结局指标
主要结局
Reduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline
时间窗: Up to 180 days
Assessment of pain reduction using the visual analogue scale (VAS) ranging from 0 to 100 mm (where 0 = absent and 100 = strongest pain)
次要结局
- Clinical improvement assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Up to 180 days)
- Improved range of motion (ROM) of the knee joint(Up to 180 days)
研究者
研究点 (1)
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