Clinical trial · Interventional
Endobronchial Valves in Persistent Air Leak
Efficacy of Endobronchial Valves in Persistent Air Leak After Anatomical Pulmonary Resection for Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Lung | Malignant Lung Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EndoBronchial Valve | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- endobronchial valve
- description
- The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.
- interventionNames
- Device: EndoBronchial Valve
Primary outcomes (1)
- measure
- clinical efficacy
- timeFrame
- One month
- description
- Clinical efficacy on air leak cessation allowing drain(s) removal.
Secondary outcomes (1)
- measure
- Safety
- timeFrame
- One month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDDooms 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 24232700