Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 12
- 主要终点
- Incidence of major adverse events, infections and device deficiencies
研究概览
简要总结
The goal of this observational study is to learn about the performance of the drainova® ArgentiC Catheter in clinical routine, which is used to treat fluid accumulations in hollow body structures. The device is already on the market and participants receive the catheter as part of their regular treatment.
The main questions of this study are:
- Does the device function as intended?
- Are there any other safety risks that have not been identified?
- Does it lower the symptoms of the patients as intended?
Doctors and patients will answer questions regarding the improvement of the patients´ symptoms and if there were any problems with the catheter.
详细描述
The drainova® ArgentiC Catheter initially received the CE mark in 2019 under the Medical Device Directive 93/42/EEC, thus being considered a legacy device under the Medical Device Regulation (EU) 2017/745 (MDR). In order to fulfill the requirements of the MDR, this PMCF study is planned to be conducted to obtain clinical data on the device confirming its safety, performance and clinical benefit in clinical routine according to the instructions for use (IFU).
This PMCF study is performed as a purely observational activity within the current standards of care and without additional invasive or burdensome procedures. The drainova® ArgentiC catheter is a catheter indicated for the treatment of patients with pleural effusions and ascites, both in the malignant and non-malignant manifestations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old
- •Patients being able to give informed consent
排除标准
- •Patients with any contraindication according to the IFU:
- •presence of septa in the body cavity
- •coagulopathy
- •infection in the body cavity
- •lymphatic effusion
- •shift of the mediastinum (by more than 2 cm to the ipsilateral side of the pleural effusion)
- •known allergies to any of the materials used in the drainage product
结局指标
主要结局
Incidence of major adverse events, infections and device deficiencies
时间窗: Up to three months post-implanatation
Frequency of device- and/ or procedure-related major adverse events (MAEs), infections and device deficiencies
Ascites- and pleural effusion-associated symptom relief
时间窗: Discharge (1-7 days post-implantation)
Measured by assessing the VAS score of the patient´s symptoms (e.g. pain) at baseline and discharge (defined by clinical routine).
Catheter patency
时间窗: Discharge (1-7 days post-implantation)
Occurrence of catheter blockage, occlusion or displacement
Implantation success
时间窗: Immediately after procedure
Must meet the following items: 1. Successful placement at the defined location 2. Feasibility of initial drainage of fluid (volume in ml)
次要结局
- Improvement of the patients´ quality-of-life vs. baseline(discharge (1-7 days post-implantation), 30 days, 3 months)