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Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414905
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : August 10, 2021
Sponsor:
Collaborator:
Merit Medical Systems, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
Indwelling tunneled pleural catheters have been successfully used to palliate dyspnea associated with recurrent malignant pleural effusions with few complications and spontaneous pleurodesis occurring in 30-50% of patients when using vacuum assisted drainage systems. Notably, all data on palliation of dyspnea as well as on rates of spontaneous pleurodesis have been performed using indwelling tunneled pleural catheters with vacuum assisted drainage systems. No current data exists regarding the efficacy, complications or rate of spontaneous pleurodesis when using indwelling tunneled pleural catheters and non-vacuum assisted drainage systems. This study is designed to evaluate an indwelling tunneled pleural catheter with a non-vacuum assisted drainage system for the management of recurrent malignant pleural effusions.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Device: Aspira Catheter Procedure: Ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : October 31, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Aspira Catheter & Drainage System
  • Participants will have standard of care ultrasound and placement of the Aspira Catheter and Drainage System on Day 1
  • The removal of the Aspira Catheter and Drainage System will be dependent upon future ultrasound assessment and fluid output
 Device: Aspira Catheter
-15.5Fr catheter
Other Name: Aspira Catheter and Drainage System

Procedure: Ultrasound
Standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Relief of dyspnea as measured using the Visual Analog Scale for Dyspnea (VAS-Dyspnea) [ Time Frame: Through 2 weeks following catheter insertion ]
    • This will be determined based on the difference between the VAS-Dyspnea score on the day of catheter insertion prior to catheter insertion compared with the VAS-Dyspnea score on the 2 week follow up visit
    • The scale presents the question "how much shortness of breath are you having right now?" with a straight line. At one end it states "no shortness of breath" and the other end is "shortness of breath as bad as can be". The participant will mark the line on how they feel
    • No shortness is breath is 0% score and shortness of breath as bad as can be is 100% score


Secondary Outcome Measures :
  1. Rate of infection [ Time Frame: 1 year ]
    -Defined as the isolation of any bacteria within a pleural fluid specimen drawn for clinical purposes

  2. Rate of spontaneous pleurodesis [ Time Frame: 1 year ]
    -Defined as pleural fluid drainage less than 75ml every other day for three consecutive drainage sessions


Eligibility Criteria
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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:

  • Male or female, at least 18 years of age, inclusive

  • Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true

    • There is cytological confirmation of pleural malignancy
    • The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum protein >0.5, Pleural fluid LDH/Serum LDH >0.6, or Pleural fluid LDH >2/3 the upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
  • Subject is able to provide informed consent
  • Subject is willing and able to meet study requirements, including follow up visits
  • Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
  • Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health).

Exclusion Criteria:

  • Patients who refuse to participate
  • Are less than 18 years of age
  • Are pregnant
  • Are unable to provide informed consent
  • Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
  • Subjects with uncorrected coagulopathy
  • All patients whom do not have malignant pleural effusions as outlined in the "definitions" section
Contacts and Locations
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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): NCT03414905


Contacts
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Contact: Alexander Chen, M.D. 314-454-8764 chenac@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Alexander Chen, M.D.    314-454-8764    chenac@wustl.edu   
Principal Investigator: Alexander Chen, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Merit Medical Systems, Inc.
Investigators
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Principal Investigator: Alexander Chen, M.D. Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03414905    
Other Study ID Numbers: 201708040
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms