New tube could ease breathing for cancer patients with Fluid-Filled lungs
NCT ID NCT02227732
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new type of tube (catheter) placed in the chest to drain fluid caused by cancer. Ten adults with recurrent, cancer-related fluid buildup around the lungs received the device. Researchers checked how safe it was and how well it worked to relieve symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- New indwelling pleural catheter
- What this could lead to
- If successful, this catheter could offer a safer, more effective way to manage fluid buildup in the chest caused by cancer, improving breathing and comfort.
- What could go wrong
- This is a very small pilot study with only 10 participants, so results may not apply to everyone. The device may cause side effects like infection or blockage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Start date
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Apr 2014
- Finished
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May 2015
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject is ≥ 18 years old. 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: 1. Subject has significant trapped lung (\>20%), or a proximal bronchial obstruction which is likely to lead to trapped lung. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Southmead Hospital - Academic Resporatory Unit
Westbury on Severn, Bristol, BS10 5NB, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.