Clinical trial: Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy. (NCT01952327)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment