The ACES Study for Aseptic Pleural Effusion

Launched by PLEURAL DYNAMICS, INC. · Jan 8, 2024

Keywords

ClinConnect Summary

The ACES Study is looking at a treatment for patients who have a condition called recurrent aseptic pleural effusion, which is when fluid builds up in the space around the lungs without an infection. This study aims to see how well a device called a catheter can help control this fluid. To join the study, participants need to have had previous fluid removal procedures and show symptoms like shortness of breath or chest discomfort. They should also be able to follow the study's requirements, which include attending follow-up visits.

If someone is eligible and agrees to participate, they will have some initial tests, including a physical exam and imaging of the chest, to assess their condition. After the catheter is placed, they will stay in the hospital for observation before going home. Participants will also be given electronic diaries to help track any pain and difficulty breathing they experience at home. This study is currently recruiting patients of all genders, aged 16 and older.

Gender

ALL

Eligibility criteria

• 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.