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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06210685
Other study ID # CL2301
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date December 2025

Study information

Verified date January 2024
Source Pleural Dynamics, Inc.
Contact Martin Mayse, MD
Phone 314.518.1786
Email research@pleuraldynamics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will enroll recurrent aseptic pleural effusion patients who are designated by their physician as needing treatment to control the fluid. Baseline assessment will include a history and physical, chest imaging and quality of life questionnaires. After ACES implantation, patients will remain under hospital care for general observation as per standard-of-care before being discharged home with access to electronic diaries for tracking pain and dyspnea.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date December 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: 1. Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated. 2. Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 4. Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls. Exclusion Criteria: 1. Recurrent pleural effusion after thoracentesis for which the physician has determined that a catheter implantation is indicated. 2. Symptoms of PE such as shortness of breath, cough, or chest fullness/chest discomfort based on patient report to physician. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 4. Patient is willing and able to meet all study requirements, including follow-up visits and receiving study related telephone calls.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Automatic Continuous Effusion Shunt implantation
The catheter pump chamber is placed with part of the chamber between adjacent ribs and part of the chamber under the skin and external to the ribs. The pump chamber is used to transfer pleural fluid into the peritoneal cavity.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pleural Dynamics, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Efficacy Endpoint Percentage change in pleural effusion volume via chest CT from baseline 30 days
Secondary Adverse Events Rate of Adverse Events (serious and non-serious) including hospitalizations/visits 30 and 60 days
Secondary Pleurodesis Rate of Pleurodesis 30 and 60 days
Secondary VAS Breathlessness Score Change in VAS Breathlessness Score 30 and 60 days
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