CompletedNot Applicable

Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter

United States119 participantsStarted 2016-05

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. There is histocytological confirmation of pleural malignancy
✓. The effusion is an exudate (per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified.

Exclusion criteria

✕. A CXR shows hydropneumothorax.
✕. A CXR shows ≥20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.
✕. A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough).

What they're measuring

The Proportion of Subjects Achieving Pleurodesis Without Recurrence.

Timeframe: 30 days post catheter insertion

Trial details

NCT IDNCT02649894

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-04-18

Results submitted2020-07-29

View on ClinicalTrials.gov More Malignant Pleural Effusion trials