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

The Washington University

Status: Completed

Conditions: Malignant Pleural Effusion

Treatments: Device: Aspira Catheter; Procedure: Ultrasound

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03414905

201708040

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Aspira Catheter & Drainage System

Description:

* 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

Treatment:

Device: Aspira Catheter

Procedure: Ultrasound