Status:
COMPLETED
A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions
Lead Sponsor:
C. R. Bard
Conditions:
Malignant Pleural Effusions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years old.
- Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:
- There is histocytological confirmation of pleural malignancy
- The effusion is an exudate (as per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
- Subject has a history of at least one ipsilateral pleural effusion causing dyspnoea that responded to thoracentesis where the lung expanded and the dyspnoea was relieved.
- Subject is willing and able to provide written informed consent.
- Subject is willing and able to meet all study requirements, including attending follow-up visits or receiving trial-related telephone calls.
- There is sufficient fluid on thoracic ultrasound to allow safe insertion of an indwelling pleural catheter
- Negative pregnancy test if appropriate
Exclusion
- Subject has significant trapped lung (\>20%), or a proximal bronchial obstruction which is likely to lead to trapped lung.
- Subject has a Karnofsky score of less than 50, or a WHO/ECOG performance status of 3\* or more.
- Subject is pregnant, planning to become pregnant, or is lactating.
- Subject has a history of empyema.
- Subject has a history of chylothorax.
- Subject has an uncorrected coagulopathy.
- Subject is allergic to device materials.
- Subject has evidence, in the opinion of the Chief Investigator, of either on-going systemic or pleural infection.
- Subject has had a lobectomy or pneumonectomy on the side of the effusion.
- Subject has undergone a previous attempt at pleurodesis which has failed.
- Subject has previously been diagnosed with a serious immunodeficiency disorder.
- Subject has bilateral pleural effusions, with both being at least moderate in size (greater than 1/3 of the hemithorax on chest x-ray).
- Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.
- Subject has a mediastinal shift of ≥2cm toward the side of the effusion.
- Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the ipsilateral chest.
- Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Chief Investigator, would mean participation in the study would be contraindicated.
- Subject has no access to a telephone
- No details of blood values (full blood count, clotting screen, urea and electrolytes, liver function) from within the last 10 days \* Patients who have a performance status of 3 may be considered for the trial if the removal of their fluid would likely improve their performance score by 1 or more.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02227732
Start Date
April 1 2014
End Date
May 1 2015
Last Update
November 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Southmead Hospital - Academic Resporatory Unit
Westbury on Severn, Bristol, United Kingdom, BS10 5NB