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New tube could ease breathing for cancer patients with Fluid-Filled lungs

NCT ID NCT02227732

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

10 people

The number who actually took part.

Start date

Apr 2014

Finished

May 2015

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Pleural Effusion, Malignant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 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.