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

NCT02649894 | Completed Results DMC

• 1 other identifier: CS-IP-VH-14-009
• Study Type: interventional
• Target: 119
• Locations: 2 countries
• Sites: 19

Brief 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.

Conditions

Malignant Pleural Effusion

Keywords

malignant pleural effusion

Outcome Measures

Primary Outcomes (1)

• The Proportion of Subjects Achieving Pleurodesis Without Recurrence.

  30 days post catheter insertion

Secondary Outcomes (2)

• Time to Confirmed Pleurodesis

  30 days post insertion

• Time to Recurrence

  90 days post insertion

Other Outcomes (5)

• Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days.

  Day 14, Day 30, Day 60, Day 90

• Proportion of Subjects With Confirmed Pleurodesis and Without Recurrence 30 Days After IPC Placement by Cancer Type (Lung, Breast and Others).

  30 days.

• Incidence of IPC Occlusion

  90 days

Study Arms (2)

Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

EXPERIMENTAL

Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Device: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Approved Uncoated PleurX Indwelling Pleural Catheter

ACTIVE COMPARATOR

Approved Uncoated PleurX Indwelling Pleural Catheter

Device: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

Interventions

Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter DEVICE

Approved Uncoated PleurX Indwelling Pleural Catheter

Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC) DEVICE

Also known as: SNCIPC

Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. 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).

You may not qualify if:

• \. 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).
• \. 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.
• \. 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.
• \. Subject has evidence, in the opinion of the Investigator, of either on-going systemic or pleural infection.
• \. 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.
• \. Subject has previously been diagnosed with a serious immunodeficiency disorder.
• \. Subject has bilateral pleural effusions, with both being at least moderate in size (greater than one-third of the hemithorax on CXR).
• \. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.
• \. 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.
• \. 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.
• \. 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (19)

Heart Center Research

Huntsville, Alabama, 35801, United States

Location

Stanford University School of Medicine/ Stanford Cancer Institute

Stanford, California, 94305, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern Unversity

Chicago, Illinois, 60611, United States

Location

St. Vincent Medical Group

Indianapolis, Indiana, 46260, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deconess Medical Center West

Boston, Massachusetts, 02215, United States

Location

Washington Universtiy School of Medicine, Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

SUNY Upstate Hospital

Syracuse, New York, 13210, United States

Location

UNC Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Vanderbuilt University

Nashville, Tennessee, 37232, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Southmead Hospital

Bristol, United Kingdom

Location

Oxford Center for Respiratory Medicine, Churchill Hospital

Oxford, United Kingdom

Location

Great Western Hospital

Swindon, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35363591 DERIVED

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dawn Heimer
• Organization: Becton Dickinson

dawn.heimer@bd.com

2018476800

Study Officials

• Joseph B Shrager, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: January 8, 2016
• Study Start: May 1, 2016
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: December 11, 2025
• Results First Posted: August 13, 2020

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (16); GB (3)