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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TERMINATED
NA
75 participants
INTERVENTIONAL
2015-05-31
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Spiration Valve System
The treatment group will have valves deployed to achieve leak isolation.
Spiration Valve System
Medical Management
The control group for this study will receive standard chest tube drainage management and standard-of-care interventions. This group will be evaluated and followed in the same manner as the treatment group, but without having valves placed.
No interventions assigned to this group
Interventions
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Spiration Valve System
Eligibility Criteria
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Inclusion Criteria
* Subject has air leak present on at least the 5th day following origination.
Exclusion Criteria
* Subject has sepsis
* Subject has pneumonia
* Subject has Acute Respiratory Distress Syndrome (ARDS)
* Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
* Subject has undergone a bone marrow transplant
* Subject has a primary pneumothorax
* Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.
18 Years
ALL
No
Sponsors
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Olympus Corporation of the Americas
INDUSTRY
Responsible Party
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Locations
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Sparks Regional Medical Center
Fort Smith, Arkansas, United States
El Camino Hospital
Mountain View, California, United States
California Pacific Medical Center
San Francisco, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Southern Illinois University
Springfield, Illinois, United States
Olathe Medical Center
Olathe, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Dartmouth Mary Hitchcock Memorial Hospital
Hanover, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
The Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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13
Identifier Type: -
Identifier Source: org_study_id
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