Spiration Valves Against Standard Therapy (VAST)

April 2, 2024 updated by: Olympus Corporation of the Americas

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Sparks Regional Medical Center
    • California
      • Mountain View, California, United States, 94040
        • El Camino Hospital
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Illinois
      • Springfield, Illinois, United States, 62794
        • Southern Illinois University
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Olathe Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Rochester
    • New Hampshire
      • Hanover, New Hampshire, United States, 03755
        • Dartmouth Mary Hitchcock Memorial Hospital
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • INOVA Fairfax Hospital
    • Washington
      • Seattle, Washington, United States, Jed Gorden
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Air Leak Cessation
Time Frame: Two weeks
Two weeks

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of SAE
Time Frame: Six weeks
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olympus Corporation of the Americas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimated)

March 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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