Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spiration IBV® Valve System and Spiration Airway Sizing Kit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01872312
Recruitment Status : Unknown
Verified February 2014 by Shaheen Islam, Ohio State University.
Recruitment status was:  Recruiting
First Posted : June 7, 2013
Last Update Posted : February 10, 2014
Sponsor:
Collaborator:
Spiration, Inc.
Information provided by (Responsible Party):
Shaheen Islam, Ohio State University

Brief Summary:
This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.

Condition or disease Intervention/treatment Phase
Management of BPF (Bronchopleural Fistulae) Device: treatment with valves (The Spiration® IBV Valve System) Not Applicable

Detailed Description:
IBV® Valve System The Spiration® IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to 6 weeks per prolonged air leak.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Humanatarian Use of the Spiration IBV® Valve System and Spiration Airway Sizing Kit for Use in Patients at The Ohio State University Medical Center.
Study Start Date : March 2012
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
treatment
Loading IBV® Valve System
Device: treatment with valves (The Spiration® IBV Valve System)
treat BPF
Other Names:
  • spiration valve
  • IBV Valve System




Primary Outcome Measures :
  1. resolution of BPF (Bronchopleural Fistulae) [ Time Frame: 6 weeks ]
    expected resolution of BPF (Bronchopleural Fistulae) in three weeks

  2. resolutin of BPF [ Time Frame: 6 weeks ]
    anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresolved BPF
  • Not candidate for surgical repair

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): NCT01872312


Contacts
Layout table for location contacts
Contact: Melissa Michetti 6142938000 melissa.michetti@osumc.edu

Locations
Layout table for location information
United States, Ohio
OSUMC Recruiting
Columbus, Ohio, United States, 43210
Contact: Melissa Michetti         
Principal Investigator: Shaheen Islam         
Sponsors and Collaborators
Shaheen Islam
Spiration, Inc.
Investigators
Layout table for investigator information
Principal Investigator: shaheen Islam, MD Ohio State University

Layout table for additonal information
Responsible Party: Shaheen Islam, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01872312     History of Changes
Other Study ID Numbers: 2012H0033
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: February 2014

Keywords provided by Shaheen Islam, Ohio State University:
BPF(Bronchopleural fistulae)

Additional relevant MeSH terms:
Layout table for MeSH terms
Fistula
Pathological Conditions, Anatomical