Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter

Not Recruiting

Trial ID: NCT02649894


The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions compared to approve catheter.

Official Title

Pivotal Multi Center, Randomized, Controlled, Single-Blinded Study Comparing the Silver Nitrate Coated Indwelling Pleural Catheter to the Uncoated PleurX Catheter for the Management of Symptomatic, Recurrent, Malignant Pleural Effusions

Stanford Investigator(s)

Mark Francis Berry, MD
Mark Francis Berry, MD

Mylavarapu Rogers Professor of Cardiothoracic Surgery

Joseph Shrager
Joseph Shrager

Professor of Cardiothoracic Surgery


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

   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

   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


device: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

device: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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