CompletedNot Applicable

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

United Kingdom10 participantsStarted 2014-04

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. There is sufficient fluid on thoracic ultrasound to allow safe insertion of an indwelling pleural catheter
✓. Negative pregnancy test if appropriate

✕. 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.
✕. Subject is allergic to device materials.
✕. Subject has evidence, in the opinion of the Chief Investigator, of either on-going systemic or pleural infection.

Device -related safety and the number of adverse events.

Timeframe: 28 days post catheter insertion

NCT IDNCT02227732

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. There is sufficient fluid on thoracic ultrasound to allow safe insertion of an indwelling pleural catheter
✓. Negative pregnancy test if appropriate

✕. 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.
✕. Subject is allergic to device materials.
✕. Subject has evidence, in the opinion of the Chief Investigator, of either on-going systemic or pleural infection.