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Spiration Valves Against Standard Therapy (VAST)

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ClinicalTrials.gov Identifier: NCT02382614
Recruitment Status : Suspended (Interim analysis and potential modification)
First Posted : March 9, 2015
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Spiration, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Air Leaks Device: Spiration Valve System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Spiration Valve System
The treatment group will have valves deployed to achieve leak isolation.
Device: Spiration Valve System
No Intervention: 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.



Primary Outcome Measures :
  1. Time to Air Leak Cessation [ Time Frame: Two weeks ]

Other Outcome Measures:
  1. Incidence of SAE [ Time Frame: Six weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382614


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Sponsors and Collaborators
Spiration, Inc.

Responsible Party: Spiration, Inc.
ClinicalTrials.gov Identifier: NCT02382614     History of Changes
Other Study ID Numbers: 13
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: April 2018

Keywords provided by Spiration, Inc.:
Endobronchial Valve
Minimally Invasive
Intrabronchial Valves
Digital Thoracic Drainage System
Spiration Valve System
Prolonged Air Leak
Persistent Air Leak