NCT02227732
Completed
N/A
A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions
ConditionsMalignant Pleural Effusions
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Malignant Pleural Effusions
- Sponsor
- C. R. Bard
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Device -related safety and the number of adverse events.
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Device -related safety and the number of adverse events.
Time Frame: 28 days post catheter insertion
Secondary Outcomes
- pleurodesis success(60 days)
- Pleurodesis success(28 days)
Study Sites (1)
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