Spiration IBV® Valve System and Spiration Airway Sizing Kit

Management of BPF (Bronchopleural Fistulae) Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01872312
• Other study ID #: 2012H0033
• Status: Withdrawn
• Phase: N/A
• Start date: March 25, 2012
• Est. completion date: February 14, 2014

Study information

• Verified date: June 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 14, 2014
• Est. primary completion date: February 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Unresolved BPF

• Not candidate for surgical repair

Related Conditions & MeSH terms

• Fistula
• Management of BPF (Bronchopleural Fistulae)

Intervention

Device:
• treatment with valves (The Spiration® IBV Valve System)
treat BPF

Locations

Country	Name	City	State
United States	OSUMC	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Spiration, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resolution of BPF (Bronchopleural Fistulae)	expected resolution of BPF (Bronchopleural Fistulae) in three weeks	6 weeks
Primary	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