Malignant Pleural EffusionSWIFTNCT02649894

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

A study testing Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter and Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC) in people with Malignant Pleural Effusion, run by C. R. Bard at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Malignant Pleural Effusion
What is being tested?: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter and Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 19 sitesin 2 countries
Study dates: May 2016to 18 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

1. Male or female, at least 18 years of age, inclusive. 2. Subject has a symptomatic MPE 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 (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 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved.
4. Subject is willing and able to provide written informed consent. 5. Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.
6. Subject has sufficient pleural fluid to allow safe insertion of an IPC. 7. Subject has negative pregnancy test if appropriate. 8. Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member or paid healthcare professional and applies to US sites only; UK subjects will have drainage managed by home-care nurses).

Who cannot join

1. Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, 2 separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after a pleural drainage.
Significant trapped lung is deemed present if any 1 of the following criteria is met:
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).
2. Subject has a Karnofsky score <50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more.

Show all 17Show fewer

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 has a hypersensitivity to new or existing pleural catheter or it's components.
8. Subject has evidence, in the opinion of the 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 ipsilateral 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 one-third of the hemithorax on CXR).
13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.
14. Subject has a mediastinal shift of ≥2 cm 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 Investigator, would mean participation in the study would be contraindicated.
17. Subject has no access to a telephone. 18. Subject has no documented blood values (complete blood count [CBC], coagulation tests, urea and electrolytes, and liver function tests [LFTs]) within the last 10 days.
19. Subject has previously participated in any clinical trial with the investigational device.
20. Subject currently enrolled in any other clinical investigation or who has participated in any clinical investigation in the 30 days prior to starting this study.

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

United States16 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deconess Medical Center West
Boston, Massachusetts, 02215
UNC Hospital
Chapel Hill, North Carolina, 27599
Northwestern Unversity
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Heart Center Research
Huntsville, Alabama, 35801
St. Vincent Medical Group
Indianapolis, Indiana, 46260
Vanderbuilt University
Nashville, Tennessee, 37232
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Washington Universtiy School of Medicine, Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford University School of Medicine/ Stanford Cancer Institute
Stanford, California, 94305
SUNY Upstate Hospital
Syracuse, New York, 13210
Moffitt Cancer Center
Tampa, Florida, 33612

Other trials in United States

United Kingdom3 sites

Southmead Hospital
Bristol
Oxford Center for Respiratory Medicine, Churchill Hospital
Oxford
Great Western Hospital
Swindon

Other trials in United Kingdom

About this study

Official title: Pivotal Multi Center, Randomized, Controlled, Single-Blinded Study Comparing the Silver Nitrate Coated Indwelling Pleural Catheter to the Uncoated PleurX Catheter for the 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 compared to approve catheter.

Conditions: Malignant Pleural Effusion
Being tested: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter, Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Keywords: malignant pleural effusion
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.

Active Comparator: Approved Uncoated PleurX Indwelling Pleural CatheterDevice
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)Device
Also called SNCIPC

Study groups in NCT02649894
Study group	Role	What they receive
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)	Experimental	Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC) Receives: Device: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Approved Uncoated PleurX Indwelling Pleural Catheter	Active comparator	Approved Uncoated PleurX Indwelling Pleural Catheter Receives: Device: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

The Proportion of Subjects Achieving Pleurodesis Without Recurrence.
Measured: 30 days post catheter insertion

Secondary outcomes (2)

Time to Confirmed Pleurodesis
Measured: 30 days post insertion
Time to Recurrence
This endpoint was meant to measure time to recurrence; however, only 1 participant (in the SNCIPC group) had a recurrence so this outcome could not be analyzed.
Measured: 90 days post insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201618 Apr 2018

First posted8 Jan 2016 (estimated)
Study startMay 2016
Primary completion18 Apr 2018
Study completion18 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
More trials run by C. R. BardThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02649894
Sponsor's protocol ID: CS-IP-VH-14-009
Acronym: SWIFT
Status last verified: Nov 2025
First submitted: 18 Dec 2015
Last updated: 11 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Shrager JB, Bhatnagar R, Kearney CT, Retzlaff NP, Cohen E, Stanton AE, Keyes C, Wahidi MM, Gillespie C, Rahman N, Kerry AL, Feller-Kopman D, Nader D, Akulian J, Chen A, Berry M, Majid A, Reddy C, Tremblay A, Maskell NA. Silver Nitrate-coated versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1722-1729. doi: 10.1513/AnnalsATS.202111-1301OC.
PubMed 35363591

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
RecruitingObservational study
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
Pleural Neoplasm
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy

All Malignant Pleural Effusion trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivotal Multi Center, Randomized, Controlled, Single-Blinded Study Comparing the Silver Nitrate Coated Indwelling Pleural Catheter to the Uncoated PleurX Catheter for the Management of Symptomatic, Recurrent, Malignant Pleural Effusions
ClinicalTrials.gov ID: NCT02649894
Acronym / sponsor ID: SWIFT / CS-IP-VH-14-009
Conditions: Malignant Pleural Effusion
Keywords: malignant pleural effusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: May 2016
Primary completion: 18 Apr 2018 (actual)
Study completion: 18 Apr 2018 (actual)
First posted: 8 Jan 2016 (estimated)
Results: Posted 13 Aug 2020

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 compared to approve catheter.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)	Experimental	Device: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Approved Uncoated PleurX Indwelling Pleural Catheter	Active comparator	Device: Active Comparator: Approved Uncoated PleurX Indwelling Pleural CatheterApproved Uncoated PleurX 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 (6 listed)

1. Male or female, at least 18 years of age, inclusive. 2. Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:
3. Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved.
4. Subject is willing and able to provide written informed consent. 5. Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.
6. Subject has sufficient pleural fluid to allow safe insertion of an IPC. 7. Subject has negative pregnancy test if appropriate. 8. Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member or paid healthcare professional and applies to US sites only; UK subjects will have drainage managed by home-care nurses).

Key exclusion criteria (17 listed)

1. Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, 2 separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after a pleural drainage.
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).
2. Subject has a Karnofsky score <50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more.

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
Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter	Device	Approved Uncoated PleurX Indwelling Pleural Catheter
Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)Also: SNCIPC	Device	Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Primary outcome

The Proportion of Subjects Achieving Pleurodesis Without Recurrence.
Time frame: 30 days post catheter insertion

2 secondary outcomes

Time to Confirmed Pleurodesis
Time frame: 30 days post insertion
Time to Recurrence
Time frame: 90 days post insertion

Results and safety

Results posted to the registry on 13 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)	81	37
Approved Uncoated PleurX Indwelling Pleural Catheter	38	27

Primary outcome: The Proportion of Subjects Achieving Pleurodesis Without Recurrence.

Time frame: 30 days post catheter insertion. Count of participants. Unit: Participants

Measure	Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC) n = 77	Approved Uncoated PleurX Indwelling Pleural Catheter n = 37
Value	17	12

Population analysed: All participants who successfully had the catheter placed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 90 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)	56 of 77 (72.7%)	48 of 77 (62.3%)	30 of 77
Approved Uncoated PleurX Indwelling Pleural Catheter	20 of 37 (54.1%)	25 of 37 (67.6%)	7 of 37

Limitations and caveats (from the sponsor): Large number of deviations (e.g. missed procedures) affected interpretability of data \& device performance. Independent adjudication of complex endpoints may have facilitated interpretation, had it been included in the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35363591Shrager JB, Bhatnagar R, Kearney CT, Retzlaff NP, Cohen E, Stanton AE, Keyes C, Wahidi MM, Gillespie C, Rahman N, Kerry AL, Feller-Kopman D, Nader D, Akulian J, Chen A, Berry M, Majid A, Reddy C, Tremblay A, Maskell NA. Silver Nitrate-coated versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1722-1729. doi: 10.1513/AnnalsATS.202111-1301OC.
Individual participant dataSharing planned: No

Related trials for Malignant Pleural Effusion

Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
RecruitingObservational study
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
Pleural Neoplasm
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy

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.

Joseph B Shrager, MD principal investigator

Stanford University

19 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 17 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 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, 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?

Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Proportion of Subjects Achieving Pleurodesis Without Recurrence. (time frame: 30 days post catheter insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02649894, which also lists 1 linked publication.

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 11 Dec 2025.