Spiration IBV® Valve System and Spiration Airway Sizing Kit

June 24, 2022 updated by: Ohio State University

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.

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

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

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unresolved BPF
  • Not candidate for surgical repair

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resolution of BPF (Bronchopleural Fistulae)
Time Frame: 6 weeks
expected resolution of BPF (Bronchopleural Fistulae) in three weeks
6 weeks
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
6 weeks

Collaborators and Investigators

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

Sponsor

Ohio State University

Collaborators

Spiration, Inc.

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 (ACTUAL)

March 25, 2012

Primary Completion (ACTUAL)

February 14, 2014

Study Completion (ACTUAL)

February 14, 2014

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (ESTIMATE)

June 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012H0033

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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