Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)

NCT ID: NCT00684892

Last Updated: 2009-01-22

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

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).

Detailed Description

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Conditions

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Heterogeneous Emphysema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Chartis System

Intervention Type DEVICE

Assessment of airway flow and pressure

Interventions

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Chartis System

Assessment of airway flow and pressure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Heterogeneous emphysema as determined by high-resolution CT scan
* Scheduled for clinically indicated ELVR procedure

Exclusion Criteria

* Hyperexcretive chronic bronchitis or excessive sputum secretion
* Active pulmonary infection
* Active asthma or lung hyper-responsiveness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pulmonx Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Pulmonx, Inc.

Principal Investigators

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Felix Herth, MD

Role: PRINCIPAL_INVESTIGATOR

Thoraxklinik am Universitatsklinikum Heidelberg

Locations

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Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PRT01029

Identifier Type: -

Identifier Source: org_study_id

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