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

Study Overview
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Brief Summary
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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.

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

Conditions
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Malignant Pleural Effusion

Intervention / Treatment
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* Device: Aspira Catheter
* Procedure: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aspira Catheter & Drainage System<br>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<br>* 15.5Fr catheter Standard of care<br>* Other names: Aspira Catheter and Drainage System;Procedure: Ultrasound<br>* Standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of dyspnea as measured using the Visual Analog Scale for Dyspnea (VAS-Dyspnea) | 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 | Through 2 weeks following catheter insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of infection | -Defined as the isolation of any bacteria within a pleural fluid specimen drawn for clinical purposes | 1 year | 
| Rate of spontaneous pleurodesis | -Defined as pleural fluid drainage less than 75ml every other day for three consecutive drainage sessions | 1 year |