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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03414905
Collaborator
Merit Medical Systems, Inc. (Industry)
40
1
75.8
0.5

Study Details

Study Description

Brief Summary

In this study, the investigators will collect data on patients who are using the Aspira system as part of their clinical care for the management of recurrent pleural effusion. Data will be collected on patient demographics, placement of the pleural catheter, palliation of dyspnea, complication rates, and rates of spontaneous pleurodesis.

Condition or Disease Intervention/Treatment Phase
  • Device: Aspira Catheter
  • Procedure: Ultrasound

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System
Actual Study Start Date :
Jul 9, 2018
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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 Standard of care
Other Names:
  • Aspira Catheter and Drainage System
  • Procedure: Ultrasound
    Standard of care

    Outcome Measures

    Primary Outcome Measures

    1. Relief of dyspnea as measured using the Visual Analog Scale for Dyspnea (VAS-Dyspnea) [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 [1 year]

      -Defined as the isolation of any bacteria within a pleural fluid specimen drawn for clinical purposes

    2. Rate of spontaneous pleurodesis [1 year]

      -Defined as pleural fluid drainage less than 75ml every other day for three consecutive drainage sessions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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:
    • Subject is pregnant

    • Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection

    • Subjects with uncorrected coagulopathy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine
    • Merit Medical Systems, Inc.

    Investigators

    • Principal Investigator: Alexander Chen, M.D., Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03414905
    Other Study ID Numbers:
    • 201708040
    First Posted:
    Jan 30, 2018
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:

    Study Results

    No Results Posted as of Mar 16, 2022