Actively Recruiting
Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
Led by Johns Hopkins University · Updated on 2025-12-17
200
Participants Needed
6
Research Sites
413 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
R
Rocket Medical plc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes.
CONDITIONS
Official Title
Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical indications for placement of IPC for malignant pleural effusion
- 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 greater than 17 years
- Sufficient fluid on ultrasound to allow for safe insertion of IPC
You will not qualify if you...
- 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
- Estimated life expectancy of less than 30 days (active hospice enrollment is allowed)
- Inability to read, understand, or write in English
- Inability to follow-up for appointments or protocol
- Any clinical or social condition that contraindicates participation
- Enrollment in alternative pleural catheter trial precluding this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Northwest Community Healthcare
Arlington Heights, Illinois, United States, 60005
Actively Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
5
Swedish Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
6
University of Oxford
Oxford, United Kingdom
Not Yet Recruiting
Research Team
I
IP Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here