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.

Study Overview

• Status: Completed
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Device: Aspira Catheter; Procedure: Ultrasound

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

• Study Contact: Name: Alexander Chen, M.D.; Phone Number: 314-454-8764; Email: chenac@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The participants will be seen at Washington University School of Medicine.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Merit Medical Systems, Inc.
• Investigators: Principal Investigator: Alexander Chen, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: 201708040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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