This is a research study examining the safety of a new, automated pump for the drainage of fluid in the chest cavity which is caused by cancer (also known as malignant pleural effusion, or MPE). The purpose of the trial is to assess whether the new pleurapump device is safe and effective in the management of patients with MPE. The study will try to identify what kind of problems may arise from using the device, how often they happen, and how severe they are if they occur.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Implantation of the pleurapump system
Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord
Marseille, France
Dept. of Respiratory Medicine, Southmead Hospital
Bristol, United Kingdom
Incidence and severity of device, procedure and therapy related serious adverse events.
Incidence and severity of device, procedure and therapy related serious adverse events.
Time frame: 3 months
Efficacy of treatment as assessed by the volume of fluid removed
Efficacy of treatment as assessed by the volume of fluid removed by the pump
Time frame: 3 months
Need for further intervention to manage pleural fluid (on the side of the intervention)
Need for further intervention to manage pleural fluid (on the side of the intervention), including therapeutic thoracentesis of greater than 100mls, insertion of an indwelling catheter, insertion of an intercostal drain for fluid management, or thoracoscopy.
Time frame: 3 months
Subjective thoracic pain on the side of the intervention
Subjective thoracic pain on the side of the intervention (measured using VAS score)
Time frame: 3 months
Subjective abdominal pain
Subjective abdominal pain (measured using VAS score)
Time frame: 3 months
Subjective breathlessness
Subjective breathlessness (measured using VAS score)
Time frame: 3 months
Quality of life
Quality of life, measured using EQ-5D health questionnaires
Time frame: 3 months
Costs of health resource use
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Costs of health resource use over the study period
Time frame: 3 months