Endobronchial Valves in Persistent Air Leak
Efficacy of Endobronchial Valves in Persistent Air Leak After Anatomical Pulmonary Resection for Cancer.
1 other identifier
interventional
10
1 country
1
Brief Summary
Because an endobronchial valve is a one-way inspiratory airway blocker, it is hypothesized that it could be also used for controlling persistent air leaks while maintaining the drainage of secretions. The U.S. Food and Drug Administration approved in October 2008 the Spiration valve system designed to control air leaks in the lung that persist after lung surgery. This prospective observational study aims to evaluate the efficacy and safety of Spiration endobronchial valves in a prospective series of consecutive patients with a prolonged persistent air leak after anatomic surgical resection for cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
October 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 10, 2013
October 1, 2011
2 years
October 4, 2011
October 8, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
clinical efficacy
Clinical efficacy on air leak cessation allowing drain(s) removal.
One month
Secondary Outcomes (1)
Safety
One month
Study Arms (1)
endobronchial valve
EXPERIMENTALThe implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.
Interventions
The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.
Eligibility Criteria
You may qualify if:
- Prolonged (≥10 days postoperative) persistent air leak refractory to conventional treatments (such as prolonged drainage and/or chemical pleurodesis).
- Anatomical lung resection such as segmentectomy, (bi)lobectomy or sleeve lobectomy.
- Air leak after antero/posterolateral thoracotomy or video-assisted thoracoscopy (VATS).
- Type of air leak : expiratory.
- Size of air leak : any.
You may not qualify if:
- Prolonged air leak \<10 days postoperative.
- Pneumonectomy or none-anatomical lung resection.
- Lung resection for another indication than cancer.
- Previous reintervention or previous Heimlich valve for this air leak.
- Empyema
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven
Leuven, Belgium
Related Publications (1)
Dooms CA, Decaluwe H, Yserbyt J, De Leyn P, Van Raemdonck D, Ninane V. Bronchial valve treatment for pulmonary air leak after anatomical lung resection for cancer. Eur Respir J. 2014 Apr;43(4):1142-8. doi: 10.1183/09031936.00117613. Epub 2013 Nov 14.
PMID: 24232700DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chrtistophe Dooms, MD, PhD
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2011
First Posted
October 13, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
October 10, 2013
Record last verified: 2011-10