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 |
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.
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
sites
330 Brookline Ave
Boston, Massachusetts 02215
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
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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1211 Medical Center Dr
Nashville, Tennessee 37232
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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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
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
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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Dallas, Texas 75390
Principal Investigator: Muhanned Abu-Hijleh, MD
Phone: 214-645-9730
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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
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
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
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
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
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
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
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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