An observational study in Malignant Pleural Effusion, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Washington University School of Medicine · Observational
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.
The participants will be seen at Washington University School of Medicine.
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
Exclusion Criteria:
* 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 · Procedure: Ultrasound
* 15.5Fr catheter * Standard of care
Also known as: Aspira Catheter and Drainage System
Standard of care
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
Time frame: Through 2 weeks following catheter insertion
Rate of infection
-Defined as the isolation of any bacteria within a pleural fluid specimen drawn for clinical purposes
Time frame: 1 year
Rate of spontaneous pleurodesis
-Defined as pleural fluid drainage less than 75ml every other day for three consecutive drainage sessions
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine