Pleural Catheter (SNCIPC) for Malignant Pleural Effusions (SWIFT)
Research type
Research Study
Full title
A Pivotal Multi-Center, Randomized, Controlled, Single-Blinded Study Comparing the Silver Nitrate-Coated Indwelling Pleural Catheter (SNCIPC) to the Uncoated PleurX® Pleural Catheter for the Management of Symptomatic, Recurrent, Malignant Pleural Effusions
IRAS ID
182373
Contact name
Nick Maskell
Contact email
Sponsor organisation
CareFusion 2200, Inc
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IDE G150146, US FDA Investigational Device Exemption
Duration of Study in the UK
1 years, 2 months, 28 days
Research summary
Pleural effusion is a fluid build-up in the linings of the lung, which keeps coming back even after drainage. Often people who have certain types of cancer have pleural effusion. While some effusions don’t cause any problems, most cases cause difficulty in breathing for patients.\n\nOne of the treatments for pleural effusion is to insert an implantable catheter between the linings of the lung and chest wall. Draining the pleural fluid can lead to pleurodesis. Pleurodesis is when the lung lining and chest wall lining stick together, which stops the pleural fluid build up (pleural effusion).\n\nResearchers want to compare an experimental catheter (called Silver Nitrate-Coated Indwelling Pleural Catheter or SNCIPC for short) to the commonly used PleurX Pleural Catheter to find out if these products are the same or different in terms of removing fluid from the lungs and causing pleurodesis. The SNCIPC is similar to the PleurX Pleural Catheter, but the SNCIPC has a coating of silver nitrate. The purpose of the study is to test whether the addition of the silver nitrate coating to the catheter helps resolve pleural effusions as well or better than the uncoated catheter alone.\n\nIt is planned that about 119 people who have pleural effusions and who are 18 years or older will be in this study. The study will take place at about 17 study centres in the United States and 3 study centres the United Kingdom. \n\nThe study has 7 planned visits at the study centre (and 3 planned telephone calls) over a period of about 3 months (90 days). Study procedures include having blood and urine samples taken, chest x rays and questionnaires. Participants will also be asked to keep a daily diary of how they feel, the medications they are taking and how much fluid was drained during the study.\n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0131
Date of REC Opinion
20 Jun 2016
REC opinion
Further Information Favourable Opinion