A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions
2 other identifiers
interventional
10
1 country
1
Brief Summary
The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedNovember 26, 2025
November 1, 2025
1.1 years
July 8, 2014
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Device -related safety and the number of adverse events.
28 days post catheter insertion
Secondary Outcomes (3)
pleurodesis success
14 days
Pleurodesis success
28 days
pleurodesis success
60 days
Other Outcomes (5)
Breathlesness
14, 28, 60 days
Chest Pain
14, 28, 60 days
Time to pleurodesis
14, 28, 60 days
- +2 more other outcomes
Study Arms (1)
New Indwelling Pleural Catheter
OTHERInterventions
Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
Study Sites (1)
Southmead Hospital - Academic Resporatory Unit
Westbury on Severn, Bristol, BS10 5NB, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2014
First Posted
August 28, 2014
Study Start
April 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
November 26, 2025
Record last verified: 2025-11