IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study — HUD-PAS

Prolonged Air Leak Clinical Trial

Official title:
A Prospective Study With the IBV Valve System for the Treatment of Prolonged Air Leak

Status Completed

Clinical Trial Summary

Study to collect post-market safety data for HUD IBV Valve System, 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 LVRS. An air leak present on post-operative 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Prolonged Air Leak

Clinical Trial Details

NCT number	NCT01166516
Study type	Interventional
Source	Spiration, Inc.
Contact
Status	Completed
Phase	N/A
Start date	April 2010
Completion date	July 2017

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT03943511` - Discharged With Indwelling Chest Tube and Valve	N/A
Completed	`NCT02491671` - Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection	Phase 3
Active, not recruiting	`NCT06356038` - Phrenic Nerve Infiltration: Pulmonary Expansion and Pain Control	N/A
Completed	`NCT04065880` - Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation	N/A