Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thorac… (NCT01952327) | Clinical Trial Compass
TerminatedNot Applicable
Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.
France, United Kingdom2 participantsStarted 2014-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of device, procedure and therapy related serious adverse events.
. 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.)