Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System
NCT ID: NCT03414905
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2018-07-09
2024-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aspira Catheter & Drainage System
* 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
Aspira Catheter
* 15.5Fr catheter
* Standard of care
Ultrasound
Standard of care
Interventions
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Aspira Catheter
* 15.5Fr catheter
* Standard of care
Ultrasound
Standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true
* There is cytological confirmation of pleural malignancy
* The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum protein \>0.5, Pleural fluid LDH/Serum LDH \>0.6, or Pleural fluid LDH \>2/3 the upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
* Subject is able to provide informed consent
* Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
* Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health).
Exclusion Criteria
* Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
* Subjects with uncorrected coagulopathy
18 Years
ALL
No
Sponsors
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Merit Medical Systems, Inc.
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Alexander Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201708040
Identifier Type: -
Identifier Source: org_study_id
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