Malignant Pleural Effusion Clinical Trial
Official title:
Evaluation of Short and Long External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions
This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction.
Pleural effusion is a medical condition, which occurs when too much fluid collects in the
space between the lungs and the chest wall. This extra fluid makes it hard for the lungs to
fully expand and take in enough air when inhaling. Malignant pleural effusions (MPE) are
effusions related to cancer. Common symptoms of MPE include: dyspnea (shortness of breath),
cough, weight loss, and chest pain. Tunneled pleural catheters (which are inserted into the
body) are now commonly used to treat the symptoms of malignant pleural effusions by draining
this extra fluid on a daily basis. This drainage can be done and home and need not be
performed at a hospital.
The aim of this study is to evaluate the effectiveness of the shorter versus longer external
length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients'
self-rated quality of life, its ease of use, the incidence of complications, and levels of
health care provider satisfaction. The Rocket® pleural catheter has been approved by the Food
and Drug Administration (FDA) and Health Canada for the management of malignant pleural
effusions.
This study will take place in Ottawa, Ontario, and will include 100 patients who are
receiving tunnelled pleural catheters to treat their symptoms of MPE. All information
required to evaluate the Rocket® catheter will be collected from routine medical follow-up
visits. The period of time for the study is approximately 4 weeks (28 days).
The Rocket® catheter will be provided to patients who wish to participate in this study. If
patients do not wish to participate, they will receive the current standard of care (the
PleurX catheter) and will undergo the same standard medical assessments that will be
performed in this study.
All patients eligible for the study will have a regular full length Rocket catheter inserted
at baseline, with an external length of 16cm. All patients will have their catheter length
modified at 2 weeks in clinic and shortened to an external length of 5cm.
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