Spiration IBV® Valve System and Spiration Airway Sizing Kit

The Ohio State University

Status: Withdrawn

Conditions: Management of BPF (Bronchopleural Fistulae)

Treatments: Device: treatment with valves (The Spiration® IBV Valve System)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01872312

2012H0033

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Unresolved BPF
• Not candidate for surgical repair

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

treatment

Other group

Description:

Loading IBV® Valve System

Treatment:

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