Prospective, multicentric observational study on the application of ASEPT® and on results from patient surveys in palliative care

Recruiting

• Conditions: R18; J90; J91; C78.2; C78.6; K70.3; K74.3; K74.4; K74.5; K74.6

• Registration Number: DRKS00031242
• Lead Sponsor: pfm medical gmbh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

*Medical indication for an ASEPT® Pleural Drainage System or an ASEPT® Peritoneal Drainage System.
*Patient is able to grasp the nature, significance, and scope of the PMCF study.
*Patient information has been handed out and all written consents have been obtained.
*Life expectancy > 2 months.

Exclusion Criteria

*Contraindications according to the instructions for use (IFU) of the manufacturer.
* Patient is institutionalised by court or official order (MPDG §27).
*Patient is participating in another surgical clinical study that also
relates to the area of ASEPT® Pleural Drainage System or ASEPT® Peritoneal Drainage System.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of changes in patients palliative care outcome six weeks <br>after implantation of the ASEPT® Pleural or Peritoneal Drainage <br>System compared to baseline using the Palliative care Outcome Scale (POS) questionnaire.

Secondary Outcome Measures

Name	Time	Method
not available