PRO ASEPT®
Prospective, multicentric observational study on the application of ASEPT® and on results from patient surveys in palliative care
This prospective, multicentric observational study investigates the ASEPT® product family already on the market. A tunneled permanent drainageIn medicine drainage refers to the systematic withdrawal of increased or diseased fluids, gases and discharges to re-establish normal conditions catheter is implanted into the pleural cavity (pleural effusionPleural effusion is an abnormal (pathological) collection of serous fluid in the pleural space between the linings of the rib cage and lungs (pleura). It may be caused by different disorders…) or into the peritoneal cavity (ascitesAscites is the abnormal accumulation of serous fluid in the peritoneal (abdominal) cavity. It may be caused by different disorders…) and is intended for the drainage of fluid accumulations from the pleural cavity or peritoneal cavity. The ASEPT® Drainage Kits are used to connect with the ASEPT® Pleura or Peritoneal catheter thus enabling outpatient drainage of pleural effusions or ascites.
Study objectives
Primary endpoint
Evaluation of the changes in the Palliative CareThis term covers all areas in the care and support of patients of any age who are severely and incurably ill or dying. Outcome Scale (POS) of patients six weeks after implantation of an ASEPT® permanent drainage catheter compared to the presurgical condition
Descriptive analyses
- Evaluation of the changes in the Palliative care outcome scale (POS) six weeks postsurgical compared to the condition before the study surgery using a validated POS questionnaire
- Complication rate incl. incidence and severity during and after implantation of a drainage system, measured in terms of (serious) adverse events ((S)AEs) during the study period
- Handling of the ASEPT® Drainage Kits in home environment
Status of the study
Recruitment closed, study is ongoing.
Study centres
- LungenClinic Großhansdorf, Großhansdorf
- Marienhospital, Gelsenkirchen
- Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Hennigsdorf
- Evangelische Lungenklinik Berlin, Berlin-Buch
- Uniklinik RWTH Aachen, Aachen