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OpenTrials
Completed

NCT Number: NCT03414905

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

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.

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Key information

Conditions

Malignant Pleural Effusion Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspira Catheter

Device
  • 15.5Fr catheter
  • Standard of care

Other names: Aspira Catheter and Drainage System

Ultrasound

Procedure

Standard of care

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Merit Medical Systems, Inc.

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Jan 30, 2018
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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