Spiration IBV® Valve System and Spiration Airway Sizing Kit | NCT01872312

Studies
Spiration IBV® Valve System and Spiration Airway Sizing Kit

NCT01872312

Sponsor

Ohio State University

Status

Withdrawn

Last Update Posted

Jun 30, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Management of BPF (Bronchopleural Fistulae)

Interventions

treatment with valves (The Spiration® IBV Valve System)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not sure. PI is no longer at OSU.

Expanded Access Info

Start Date

Mar 25, 2012Actual

Primary Completion Date

Feb 14, 2014Actual

Completion Date

Feb 14, 2014Actual

First Submitted Date

Apr 10, 2013

First Submission Date that Met QC Criteria

Jun 6, 2013

First Posted Date

Jun 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2022

Last Update Posted Date

Jun 30, 2022Actual

Name	Class
Olympus Corporation of the Americas	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment	Other	Loading IBV® Valve System	Device: treatment with valves (The Spiration® IBV Valve System)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
treatment with valves (The Spiration® IBV Valve System)	Device	treat BPF	treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
resolution of BPF (Bronchopleural Fistulae)	expected resolution of BPF (Bronchopleural Fistulae) in three weeks	6 weeks
resolutin of BPF	anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unresolved BPF
Not candidate for surgical repair

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
shaheen Islam, MD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OSUMC		Columbus	Ohio	43210	United States

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided