A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions

The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.

Study Overview

• Status: Completed
• Conditions: Malignant Pleural Effusions
• Intervention / Treatment: Device: New Indwelling Pleural Catheter

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol
    • Westbury on Severn, Bristol, United Kingdom, BS10 5NB
      • Southmead Hospital - Academic Resporatory Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: New Indwelling Pleural Catheter	Device: New Indwelling Pleural Catheter; Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Device -related safety and the number of adverse events.	28 days post catheter insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pleurodesis success	Assessed by chest x-ray, thorachic ultrasound, and confirmation the catheter is patent.	14 days
Pleurodesis success	Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.	28 days
pleurodesis success	Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.	60 days

Other Outcome Measures

Outcome Measure	Time Frame
Breathlesness	14, 28, 60 days
Chest Pain	14, 28, 60 days
Time to pleurodesis	14, 28, 60 days
Quality of Life	14, 28, 60 days
Need for further pleural intervention post catheter removal	60 days

Collaborators and Investigators

• Sponsor: C. R. Bard

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimated): August 28, 2014

Study Record Updates

• Last Update Posted (Estimated): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Diseases; Pleural Effusion; Pleural Effusion, Malignant
• Other Study ID Numbers: CS-IS-VH-13-001; CI20130054 (Other Identifier: UK MHRA)