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

Malignant Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414905
• Other study ID #: 201708040
• Status: Completed
• Start date: July 9, 2018
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2024
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Device:
• Aspira Catheter
15.5Fr catheter Standard of care

Procedure:
• Ultrasound
Standard of care

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Merit Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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