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Indwelling Tunneled Pleural Catheter
Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System
N/A
Waitlist Available
Led By Alexander Chen, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the Aspira system, which is used to manage recurrent pleural effusion (fluid buildup around the lungs). Data will be collected on patient characteristics, Aspira system placement, symptom relief, complication rates, and rates of spontaneous pleurodesis (fluid removal without surgery).
Eligible Conditions
- Malignant Pleural Effusion
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Relief of dyspnea as measured using the Visual Analog Scale for Dyspnea (VAS-Dyspnea)
Secondary study objectives
Rate of infection
Pleurodesis
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Aspira Catheter & Drainage SystemExperimental Treatment2 Interventions
* Participants will have standard of care ultrasound and placement of the Aspira Catheter and Drainage System on Day 1
* The removal of the Aspira Catheter and Drainage System will be dependent upon future ultrasound assessment and fluid output
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~4090
Aspira Catheter
2018
N/A
~40
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,344,270 Total Patients Enrolled
Merit Medical Systems, Inc.Industry Sponsor
32 Previous Clinical Trials
3,252 Total Patients Enrolled
Alexander Chen, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
222 Total Patients Enrolled