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Spiration IBV® Valve System and Spiration Airway Sizing Kit

NCT ID: NCT01872312

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-25

Study Completion Date

2014-02-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Management of BPF (Bronchopleural Fistulae)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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treatment

Loading IBV® Valve System

Group Type OTHER

treatment with valves (The Spiration® IBV Valve System)

Intervention Type DEVICE

treat BPF

Interventions

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treatment with valves (The Spiration® IBV Valve System)

treat BPF

Intervention Type DEVICE

Other Intervention Names

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spiration valve IBV Valve System

Eligibility Criteria

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Inclusion Criteria

* Unresolved BPF
* Not candidate for surgical repair
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olympus Corporation of the Americas

INDUSTRY

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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shaheen Islam, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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OSUMC

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2012H0033

Identifier Type: -

Identifier Source: org_study_id

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