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

NCT03414905 | Completed DMC FDA Device

• 1 other identifier: 201708040
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of infection

  1 year

• Rate of spontaneous pleurodesis

  1 year

Study Arms (1)

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; Procedure: Ultrasound

Interventions

Aspira Catheter DEVICE

* 15.5Fr catheter * Standard of care

Also known as: Aspira Catheter and Drainage System

Aspira Catheter & Drainage System

Ultrasound PROCEDURE

Standard of care

Aspira Catheter & Drainage System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• Subject is pregnant
• Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
• Subjects with uncorrected coagulopathy

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Merit Medical Systems, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Alexander Chen, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: July 9, 2018
• Primary Completion: September 26, 2023
• Study Completion: February 15, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)