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Spiration IBV® Valve System and Spiration Airway Sizing Kit

Primary Purpose

Management of BPF (Bronchopleural Fistulae)

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

treatment with valves (The Spiration® IBV Valve System)

About this trial

This is an interventional other trial for Management of BPF (Bronchopleural Fistulae) focused on measuring BPF(Bronchopleural fistulae)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Unresolved BPF
Not candidate for surgical repair

Sites / Locations

OSUMC

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

treatment

Arm Description

Loading IBV® Valve System

Outcomes

Primary Outcome Measures

resolution of BPF (Bronchopleural Fistulae)

expected resolution of BPF (Bronchopleural Fistulae) in three weeks

resolutin of BPF

anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks

Secondary Outcome Measures

Full Information

NCT ID

NCT01872312

First Posted

April 10, 2013

Last Updated

June 24, 2022

Sponsor

Ohio State University

Collaborators

Olympus Corporation of the Americas

1. Study Identification

Unique Protocol Identification Number

NCT01872312

Brief Title

Spiration IBV® Valve System and Spiration Airway Sizing Kit

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 Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Not sure. PI is no longer at OSU.

Study Start Date

March 25, 2012 (Actual)

Primary Completion Date

February 14, 2014 (Actual)

Study Completion Date

February 14, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ohio State University

Collaborators

Olympus Corporation of the Americas

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Management of BPF (Bronchopleural Fistulae)

Keywords

BPF(Bronchopleural fistulae)

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Other

Arm Description

Loading IBV® Valve System

Intervention Type

Device

Intervention Name(s)

treatment with valves (The Spiration® IBV Valve System)

Other Intervention Name(s)

spiration valve, IBV Valve System

Intervention Description

treat BPF

Primary Outcome Measure Information:

Title

resolution of BPF (Bronchopleural Fistulae)

Description

expected resolution of BPF (Bronchopleural Fistulae) in three weeks

Time Frame

6 weeks

Title

resolutin of BPF

Description

anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Unresolved BPF Not candidate for surgical repair

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

shaheen Islam, MD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

OSUMC

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

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Spiration IBV® Valve System and Spiration Airway Sizing Kit

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