Malignant Pleural EffusionsNCT02227732
A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions
A study testing New Indwelling Pleural Catheter in people with Malignant Pleural Effusions, run by C. R. Bard at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusions
- What is being tested?
- New Indwelling Pleural Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
- 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.
- Subject has no access to a telephone
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southmead Hospital - Academic Resporatory Unit
Westbury on Severn, Bristol, BS10 5NB
About this study
The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.
- Conditions
- Malignant Pleural Effusions
- Being tested
- New Indwelling Pleural Catheter
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Indwelling Pleural CatheterDevice
Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.
| Study group | Role | What they receive |
|---|---|---|
| New Indwelling Pleural Catheter | Other | Not described Receives: Device: New Indwelling Pleural Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device -related safety and the number of adverse events.
Measured: 28 days post catheter insertion
Secondary outcomes (3)
pleurodesis success
Assessed by chest x-ray, thorachic ultrasound, and confirmation the catheter is patent.
Measured: 14 days
Pleurodesis success
Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.
Measured: 28 days
pleurodesis success
Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227732
- Sponsor's protocol ID
- CS-IS-VH-13-001
- Other IDs
- CI20130054
- Status last verified
- Nov 2025
- First submitted
- 8 Jul 2014
- Last updated
- 26 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions
- ClinicalTrials.gov ID
- NCT02227732
- Acronym / sponsor ID
- CS-IS-VH-13-001
- Conditions
- Malignant Pleural Effusions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Indwelling Pleural Catheter | Other | Device: New Indwelling Pleural Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Indwelling Pleural CatheterPlacement of an indwelling catheter in the pleural space. Drainage of effusions until resolution. | Device | New Indwelling Pleural Catheter |
Primary outcome
Device -related safety and the number of adverse events.
Time frame: 28 days post catheter insertion
3 secondary outcomes
pleurodesis success
Time frame: 14 days
Pleurodesis success
Time frame: 28 days
pleurodesis success
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Indwelling Pleural Catheter in people with Malignant Pleural Effusions, run by C. R. Bard at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device -related safety and the number of adverse events. (time frame: 28 days post catheter insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.