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

NCT ID: NCT02649894

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-04-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Group Type: EXPERIMENTAL

Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Intervention Type: DEVICE

Approved Uncoated PleurX Indwelling Pleural Catheter

Approved Uncoated PleurX Indwelling Pleural Catheter

Group Type: ACTIVE_COMPARATOR

Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

Intervention Type: DEVICE

Interventions

Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

Intervention Type: DEVICE

Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Intervention Type: DEVICE

Other Intervention Names

SNCIPC

Eligibility Criteria

Inclusion Criteria

• 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:

1. There is histocytological confirmation of pleural malignancy

2. 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).

Exclusion Criteria

• 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:

1. A CXR shows hydropneumothorax.

2. 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.

3. 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph B Shrager, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Heart Center Research

Huntsville, Alabama, United States

Stanford University School of Medicine/ Stanford Cancer Institute

Stanford, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern Unversity

Chicago, Illinois, United States

St. Vincent Medical Group

Indianapolis, Indiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deconess Medical Center West

Boston, Massachusetts, United States

Washington Universtiy School of Medicine, Barnes Jewish Hospital

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

SUNY Upstate Hospital

Syracuse, New York, United States

UNC Hospital

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Vanderbuilt University

Nashville, Tennessee, United States

University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Southmead Hospital

Bristol, , United Kingdom

Oxford Center for Respiratory Medicine, Churchill Hospital

Oxford, , United Kingdom

Great Western Hospital

Swindon, , United Kingdom

Countries

United States; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35363591 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CS-IP-VH-14-009

Identifier Type: -

Identifier Source: org_study_id