Status:
RECRUITING
Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Rocket Medical plc
Swedish Medical Center
Conditions:
Pleural Effusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Indwelling tunneled pleural catheters (IPCs) are used to alleviate pleural effusion as a first-line therapeutic (albeit palliative) intervention. Limited data currently exists on drainage techniques a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03831386
Start Date
January 31 2019
End Date
December 31 2026
Last Update
December 17 2025
Active Locations (6)
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1
Northwest Community Healthcare
Arlington Heights, Illinois, United States, 60005
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232