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A Clinical Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions Compared to Approved Pleural Catheter. (SWIFT)

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ClinicalTrials.gov Identifier: NCT02649894
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
CareFusion

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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Device: Indwelling Pleural Catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : May 2016
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018

Arm Intervention/treatment
Experimental: investigation product
investigation product
Device: Indwelling Pleural Catheter
Active Comparator: Approved indwelling catheter
Approved indwelling catheter
Device: Indwelling Pleural Catheter



Primary Outcome Measures :
  1. The proportion of subjects achieving pleurodesis without recurrence [ Time Frame: 30 days post catheter insertion ]

Secondary Outcome Measures :
  1. Time to confirmed pleurodesis [ Time Frame: 30 days post insertion ]
  2. Time to recurrence [ Time Frame: 90 days post insertion ]

Other Outcome Measures:
  1. Proportion of surviving subjects without a trapped lung diagnosis following IPC placement who have confirmed pleurodesis without recurrence at 14, 30, 60, 90 days. [ Time Frame: 14, 30, 60, 90 days. ]
  2. Proportion of subjects with confirmed pleurodesis and without recurrence 30 days after IPC placement by cancer type (lung, breast and others). [ Time Frame: 30 days. ]
  3. Incidence of IPC occlusion [ Time Frame: 14, 30, 60, 90 days. ]
  4. Incidence of empyema and cellulitis [ Time Frame: 14, 30, 60, 90 days. ]
  5. Pain using 100 mm visual analog scale (VAS) [ Time Frame: 14, 30, 60, 90 days. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649894


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

Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT02649894     History of Changes
Other Study ID Numbers: CS-IP-VH-14-009
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

Keywords provided by CareFusion:
malignant pleural effusion

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms