Clinical trial: Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter (NCT02649894)

Eligibility criteria:
Inclusion Criteria:

          -  1. Male or female, at least 18 years of age, inclusive. 2. Subject has a symptomatic
             MPE requiring intervention. For an effusion to be defined as malignant, at least one
             of the following must be true:

               1. There is histocytological confirmation of pleural malignancy

               2. The effusion is an exudate (per Light's criteria) in the context of
                  histocytologically proven malignancy elsewhere, with no other clear cause for
                  fluid identified.

                  3. Subject has a history of at least 1 ipsilateral pleural effusion causing
                  dyspnea that responded to thoracentesis where the lung expanded and the dyspnea
                  was improved.

                  4. Subject is willing and able to provide written informed consent. 5. Subject is
                  willing and able to meet all study requirements, including follow-up visits and
                  receiving study-related telephone calls.

                  6. Subject has sufficient pleural fluid to allow safe insertion of an IPC. 7.
                  Subject has negative pregnancy test if appropriate. 8. Subject or caregiver is
                  able to perform home drainage of the pleural effusion (a caregiver can be a
                  friend, family member or paid healthcare professional and applies to US sites
                  only; UK subjects will have drainage managed by home-care nurses).

                  Exclusion Criteria:

          -  1. Subject has significant trapped lung, or a proximal bronchial obstruction which is
             likely to lead to trapped lung. For a subject to be eligible for this study, 2
             separate study center clinicians must agree that there is no significant trapped lung
             on the same CXR using visual estimation (reference guide). The CXR used to make this
             decision must have been performed ≤30 days preceding the consent form being signed,
             and must have been performed preferably on the same day, but no more than 7 calendar
             days after a pleural drainage.

        Significant trapped lung is deemed present if any 1 of the following criteria is met:

          1. A CXR shows hydropneumothorax.

          2. A CXR shows ≥20% of the affected hemithorax to be free of the expected lung
             parenchymal markings and there is no suggestion of pleural fluid.

          3. A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a
             pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest
             pain or cough).

             2. Subject has a Karnofsky score <50, or a World Health Organization (WHO)/ Eastern
             Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a
             performance status of 3 may be considered for the study if the removal of their fluid
             would likely improve their performance score by 1 or more.

             3. Subject is pregnant, planning to become pregnant, or is lactating. 4. Subject has a
             history of empyema. 5. Subject has a history of chylothorax. 6. Subject has an
             uncorrected coagulopathy. 7. Subject has a hypersensitivity to new or existing pleural
             catheter or it's components.

             8. Subject has evidence, in the opinion of the Investigator, of either on-going
             systemic or pleural infection.

             9. Subject has had a lobectomy or pneumonectomy on the side of the effusion. 10.
             Subject has undergone a previous attempt at ipsilateral pleurodesis which has failed.

             11. Subject has previously been diagnosed with a serious immunodeficiency disorder.

             12. Subject has bilateral pleural effusions, with both being at least moderate in size
             (greater than one-third of the hemithorax on CXR).

             13. Subject has evidence of fluid loculation such that attempts at pleurodesis are
             likely to be futile.

             14. Subject has a mediastinal shift of ≥2 cm toward the side of the effusion. 15.
             Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the
             ipsilateral chest.

             16. Subject has any clinical condition, diagnosis, or social circumstance that, in the
             opinion of the Investigator, would mean participation in the study would be
             contraindicated.

             17. Subject has no access to a telephone. 18. Subject has no documented blood values
             (complete blood count [CBC], coagulation tests, urea and electrolytes, and liver
             function tests [LFTs]) within the last 10 days.

             19. Subject has previously participated in any clinical trial with the investigational
             device.

             20. Subject currently enrolled in any other clinical investigation or who has
             participated in any clinical investigation in the 30 days prior to starting this
             study.
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? 1