Trial Search Results
Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter
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.
Stanford is currently not accepting patients for this trial.
- Device: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
- Device: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
- 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
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
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).
- 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
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study