Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.

Study Overview
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Brief Summary
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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.

Official Title
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Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.

Conditions
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Pleural Effusion

Intervention / Treatment
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* Device: The pleurapump system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years of age Recurrent pleural effusion due malignancy Malignant pleural effusions are defined as either Fluid in the context of histocytologically confirmed pleural malignancy, or pleural fluid in the context of histocytologically confirmed malignancy elsewhere, with no other clear cause for the effusion. 1 or more therapeutic procedures for pleural fluid drainage prior to enrolment. Written informed consent Ability to comply with study procedures and ability to operate the device Expected survival of more than 3 months after device insertion Exclusion Criteria: Haemothorax Purulent pleural effusion Significant pleural fluid septation or loculation on thoracic ultrasound or cross-sectional imaging Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device. Pregnant females or females anticipating pregnancy during study period. Patients currently enrolled in another interventional clinical study Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to cardiac pacemaker or cardioverter defibrillator. Major comorbidity which, in the opinion of the principal investigator, is likely to significantly decrease life expectancy, increase anaesthetic risk, or lead to device removal (e.g. moderate to severe congestive heart failure, significant valvular heart disease, persistent immunosuppression, etc.) Other contraindication to general anaesthesia Other contraindication to procedure (e.g. uncorrectable bleeding diathesis, infection or malignant involvement over proposed insertion site) Significant renal impairment, as determined by the principal investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: plueurapump<br>Implantation of pleurapump system | Device: The pleurapump system<br>* Implantation of the pleurapump system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of device, procedure and therapy related serious adverse events. | Incidence and severity of device, procedure and therapy related serious adverse events. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 3 months | 
| Subjective thoracic pain on the side of the intervention | Subjective thoracic pain on the side of the intervention (measured using VAS score) | 3 months | 
| Subjective abdominal pain | Subjective abdominal pain (measured using VAS score) | 3 months | 
| Subjective breathlessness | Subjective breathlessness (measured using VAS score) | 3 months | 
| Quality of life | Quality of life, measured using EQ-5D health questionnaires | 3 months | 
| Costs of health resource use | Costs of health resource use over the study period | 3 months |