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Compares treatment options for Pleural Effusion
Official title Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
ClinicalTrials.gov ID: NCT03831386
What this study is testing
- What it's testing
- Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical indications for placement of IPC for malignant pleural effusion a. Pleural effusion with symptomatic improvement in dyspnea after drainage...
- Clinically confident symptomatic malignant pleural effusion
- Histocytological proof of pleural malignancy
- Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space
- Plans for placement of IPC within ten days of enrollment
You likely can't join if
- Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
- Pregnant or lactating mothers
- Previous ipsilateral chemical pleurodesis
- Current contralateral indwelling pleural catheter
- Known rib or thoracic skeletal metastasis causing pain
- Concern for active pleural infection
See the full eligibility criteria
- Clinical indications for placement of IPC for malignant pleural effusion a. Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion
- Clinically confident symptomatic malignant pleural effusion
- Histocytological proof of pleural malignancy
- Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space
- Plans for placement of IPC within ten days of enrollment
- Age \> 17 years
- Sufficient fluid on ultrasound to allow for safe insertion of IPC
- Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
- Pregnant or lactating mothers
- Previous ipsilateral chemical pleurodesis
- Current contralateral indwelling pleural catheter
- Known rib or thoracic skeletal metastasis causing pain
- Concern for active pleural infection
- Respiratory failure
- Irreversible bleeding diathesis
- Inability to provide care for indwelling tunneled pleural catheter
- Significantly loculated pleural space precluding drainage of pleural space, for which IPC alone will likely not offer symptomatic benefit
- Estimated life expectancy of \< 30 days (however, active enrollment in hospice program is not an exclusion criteria)
- Inability to read/understand/write in the English language
- Inability to follow-up for appointments/protocol
- Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the investigator would mean participation in the study would be contraindicated.
- Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial
The study team makes the final eligibility decision.
Where it's taking place
- Arlington Heights, Illinois, United States
- Baltimore, Maryland, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arlington Heights, Illinois, United States; Baltimore, Maryland, United States; Charleston, South Carolina, United States; Nashville, Tennessee, United States; Seattle, Washington, United States; Oxford, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.