Pleural Effusion
Conditions
Brief summary
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.
Interventions
DEVICEThe pleurapump system
Implantation of the pleurapump system
Sponsors
Sequana Medical N.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \> 18 years of age 2. 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. 3. 1 or more therapeutic procedures for pleural fluid drainage prior to enrolment. 4. Written informed consent 5. Ability to comply with study procedures and ability to operate the device 6. Expected survival of more than 3 months after device insertion
Exclusion criteria
1. Haemothorax 2. Purulent pleural effusion 3. Significant pleural fluid septation or loculation on thoracic ultrasound or cross-sectional imaging 4. Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device. 5. Pregnant females or females anticipating pregnancy during study period. 6. Patients currently enrolled in another interventional clinical study 7. Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to cardiac pacemaker or cardioverter defibrillator. 8. 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.) 9. Other contraindication to general anaesthesia 10. Other contraindication to procedure (e.g. uncorrectable bleeding diathesis, infection or malignant involvement over proposed insertion site) 11. Significant renal impairment, as determined by the principal investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of device, procedure and therapy related serious adverse events. | 3 months | Incidence and severity of device, procedure and therapy related serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for further intervention to manage pleural fluid (on the side of the intervention) | 3 months | 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. |
| Subjective thoracic pain on the side of the intervention | 3 months | Subjective thoracic pain on the side of the intervention (measured using VAS score) |
| Subjective abdominal pain | 3 months | Subjective abdominal pain (measured using VAS score) |
| Efficacy of treatment as assessed by the volume of fluid removed | 3 months | Efficacy of treatment as assessed by the volume of fluid removed by the pump |
| Quality of life | 3 months | Quality of life, measured using EQ-5D health questionnaires |
| Costs of health resource use | 3 months | Costs of health resource use over the study period |
| Subjective breathlessness | 3 months | Subjective breathlessness (measured using VAS score) |
Countries
France, United Kingdom
Outcome results
None listed