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

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 - DRAIN-FAST

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029116

Enrollment

Registered

2022-11-16

Start date

2022-11-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J90 R18

Interventions

Group 1: Patients with pleural effusion or ascites perform drainage themselves using the PleurX Drainage Minikit or with the help of relatives/caregivers as needed in the home environment. Questionnai

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Usability of the PleurX Drainage Minikit for the different user groups collected by means of a usability questionnaire 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) Change in pleural effusion/ascites associated symptoms collected by means of a questionnaire 1 week after the start of therapy (day 6 + 2) Patient satisfaction: documented in the study diary/questionnaire for each individual drainage User satisfaction: documented in the study diary/questionnaire for each individual drainage Proportion of the respective user groups	—

Measure

Time frame

Usability of the PleurX Drainage Minikit for the different user groups collected by means of a usability questionnaire 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) Change in pleural effusion/ascites associated symptoms collected by means of a questionnaire 1 week after the start of therapy (day 6 + 2) Patient satisfaction: documented in the study diary/questionnaire for each individual drainage User satisfaction: documented in the study diary/questionnaire for each individual drainage Proportion of the respective user groups

—

Countries

Germany

Contacts

Public ContactServet Bölükbas

Universitätsmedizin Essen - Ruhrlandklinik Klinik für Thoraxchirurgie und thorakale Endoskopie

Servet.Boeluekbas@rlk.uk-essen.de+49 201 433 4011

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026