Prospective study to demonstrate safety and usability as well as a positive healthcare effect in the domestic use of the PleurX Drainage Minikit for the drainage of pleural effusions and ascites

Active, not recruiting

• Conditions: J90; R18; Pleural effusion, not elsewhere classified; Ascites

• Registration Number: DRKS00029116
• Lead Sponsor: Becton Dickinson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-16
• Study Completion: 2023-12-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Medically diagnosed benign or malignant pleural effusion or ascites with indication for drainage by the PleurX Drainage Minikit.

2. Patient must be able to be discharged to the home environment after catheter has been implanted

3. Age: at least 18 years

4. Patients must be able to understand patient information

5. Patients must be willing and able to meet the requirements of the study

6. Signed declaration of informed consent

Exclusion Criteria

1. Patients with a life expectancy < 2 months (doctor's assessment)

2. Patients with planned hospital stays

3. Patients with problems/inflammations at the catheter exit point

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the number of safe and efficient drains, which are quantified by the number of applications by different user groups without use errors. The required data are collected after each drainage by means of a study diary/questionnaire.

Secondary Outcome Measures

Name	Time	Method
sability of the PleurX Drainage Minikit for the different user groups collected by means of a usability questionnaire<br><br>Improvement of the patient's quality of life collected by means of questionnaires (SF-36; MQOL-R) immediately after inclusion (day 0) and 1 week after start of therapy (day 6 +2) <br><br>Change in pleural effusion/ascites associated symptoms collected by means of a questionnaire 1 week after the start of therapy (day 6 + 2)<br><br>Patient satisfaction: documented in the study diary/questionnaire for each individual drainage <br><br>User satisfaction: documented in the study diary/questionnaire for each individual drainage <br><br>Proportion of the respective user groups