A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions
NCT ID: NCT02227732
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2014-04-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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New Indwelling Pleural Catheter
New Indwelling Pleural Catheter
Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.
Interventions
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New Indwelling Pleural Catheter
Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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.
4. Subject is willing and able to provide written informed consent.
5. Subject is willing and able to meet all study requirements, including attending follow-up visits or receiving trial-related telephone calls.
6. There is sufficient fluid on thoracic ultrasound to allow safe insertion of an indwelling pleural catheter
7. Negative pregnancy test if appropriate
Exclusion Criteria
2. Subject has a Karnofsky score of less than 50, or a WHO/ECOG performance status of 3\* 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 is allergic to device materials.
8. Subject has evidence, in the opinion of the Chief 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 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 1/3 of the hemithorax on chest x-ray).
13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.
14. Subject has a mediastinal shift of ≥2cm 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 Chief Investigator, would mean participation in the study would be contraindicated.
17. Subject has no access to a telephone
18. 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.
18 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Locations
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Southmead Hospital - Academic Resporatory Unit
Westbury on Severn, Bristol, United Kingdom
Countries
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Other Identifiers
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CI20130054
Identifier Type: OTHER
Identifier Source: secondary_id
CS-IS-VH-13-001
Identifier Type: -
Identifier Source: org_study_id
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