Spiration Valves Against Standard Therapy



Status:Suspended
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:May 2015
End Date:December 2019

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Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks

VAST is a multicenter, prospective, randomized, controlled study designed to evaluate
treatment of persistent air leak with the SVS as compared to standard chest tube drainage
management and other standard-of-care interventions in the control group. Eligible subjects
will be randomized to receive either Spiration Valves (investigational arm) or continue
standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves
should be removed.


Inclusion Criteria:

- Subject has an air leak ≥ 100 mL/min, as measured by a digital thoracic drainage
system (DTDS)

- Subject has air leak present on at least the 5th day following origination.

Exclusion Criteria:

- Subject has air leak only on forced exhalation or cough

- 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.
We found this trial at
20
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Adnan Majid, MD
Phone: 617-632-8386
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Amit Mahajan, MD
Phone: 703-776-7882
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Otis Rickman, DO
Phone: (615) 343-0266
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Whitney Burrows, MD
Phone: 410-328-6366
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Burlington, Massachusetts 01805
Principal Investigator: Carla Lamb, MD
Phone: 781-744-3706
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Burlington, MA
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Sadia Benzaquen, MD
Phone: 513-558-0027
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Kiranmayee Lanka, MD
Phone: 513-585-1777
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cincinnati, OH
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Dallas, Texas 75390
Principal Investigator: Muhanned Abu-Hijleh, MD
Phone: 214-645-9730
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Fort Smith, Arkansas 72901
Phone: 479-441-5671
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Fort Smith, AR
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Hanover, New Hampshire 03755
Principal Investigator: David Finley, MD
Phone: 603-653-9399
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Hershey, Pennsylvania 17033
Principal Investigator: Michael Reed, MD
Phone: 717-531-6010
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2500 Grant Rd
Mountain View, California 94040
(650) 940-7000
Principal Investigator: Ganesh Krishna, MD
Phone: 650-962-4463
El Camino Hospital El Camino Hospital is a nonprofit organization with hospital campuses in Mountain...
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Olathe, Kansas 66061
Principal Investigator: Dennis Lawlor, MD
Phone: 913-829-0446
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Gerard Criner, MD
Phone: 215-707-1559
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: K. Robert Shen, MD
Phone: 507-266-4819
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Benson Chen, MD
Phone: 415-600-1368
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Jed Gorden, MD
Phone: 206-386-2450
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Principal Investigator: Stephen Hazelrigg, MD
Phone: 217-545-7799
Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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