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

Status: Completed
Location: See location...
Intervention Type: Device, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Missouri
Washington University School of Medicine
St Louis
Time Frame
Start Date: 2018-07-09
Completion Date: 2024-02-15
Participants
Target number of participants: 40
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: Merit Medical Systems, Inc.

This content was sourced from clinicaltrials.gov