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A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)

NCT ID: NCT01101958

Last Updated: 2017-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-03-31

Brief Summary

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Use of the Chartis® Assessment System prior to EBV Treatment

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Detailed Description

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This is a multi-center study which will enroll up to 120 patients. Subjects will undergo a Chartis Assessment prior to EBV treatment. The Chartis assessment will determine the presence or absence of collateral ventilation, a potential determining factor in the success of EBV therapy. This study is not randomized; all subjects are eligible to receive EBV Treatment, regardless of Chartis Assessment outcome. Follow-up data will only be collected on those patients that meet the Chartis inclusion criteria.

Conditions

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Emphysema

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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Chartis System-EBV Treatment

Subjects with heterogeneous emphysema, had their collateral ventilation status in the target treatment lobe assessed using the Chartis System (CV- or CV+) and underwent endobronchial lung volume reduction (ELVR) with endobronchial valves (EBV).

Group Type OTHER

Chartis System

Intervention Type DEVICE

The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.

Endobronchial Valve (EBV) Treatment

Intervention Type DEVICE

The endobronchial valve is designed to induce target lobe volume reduction.

Interventions

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Chartis System

The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.

Intervention Type DEVICE

Endobronchial Valve (EBV) Treatment

The endobronchial valve is designed to induce target lobe volume reduction.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Heterogeneous emphysema
* Able to obtain a Chartis value during Assessment

Exclusion Criteria

* Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pulmonx Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Heidelberg

Heidelberg, , Germany

Site Status

UMC Groningen

Groningen, , Netherlands

Site Status

Countries

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Germany Netherlands

References

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Herth FJ, Eberhardt R, Gompelmann D, Ficker JH, Wagner M, Ek L, Schmidt B, Slebos DJ. Radiological and clinical outcomes of using Chartis to plan endobronchial valve treatment. Eur Respir J. 2013 Feb;41(2):302-8. doi: 10.1183/09031936.00015312. Epub 2012 May 3.

Reference Type DERIVED
PMID: 22556025 (View on PubMed)

Other Identifiers

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630-0011

Identifier Type: -

Identifier Source: org_study_id

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