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Endobronchial Valves in Persistent Air Leak

NCT ID: NCT01451359

Last Updated: 2013-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Persistent Air Leak (PAL) is independently associated with prolonged hospital length of stay, decreased patient satisfaction, increased morbidity or postoperative complications, and adds significantly to the cost. The management of air leaks is primarily preventive and therefore starts in the operating room with surgical techniques that can minimize the occurrence of post-operative air leaks, such as the creation of pleural tents or use of suture line glues or sealants. Notwithstanding some patients will after a lung resection have PAL. Any minimal invasive method that helps to increase our ability to treat (reduce and/or stop) the air leak in these latest cases carries an enormous clinical as well as cost-saving potential. Bronchoscopic occlusion of a segmental or subsegmental bronchus using endobronchial valves is such a less invasive method which has shown in case reports to interrupt an air leak.

Conditions

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Malignant Neoplasm of Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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endobronchial valve

The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.

Group Type EXPERIMENTAL

EndoBronchial Valve

Intervention Type DEVICE

The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.

Interventions

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EndoBronchial Valve

The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.

Intervention Type DEVICE

Other Intervention Names

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Spiration IBV™ valve system

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chrtistophe Dooms, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 24232700 (View on PubMed)

Other Identifiers

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s51545

Identifier Type: -

Identifier Source: org_study_id