NCT00684892

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

Enrollment Period

6 months

First QC Date

May 23, 2008

Last Update Submit

January 20, 2009

Conditions

Heterogeneous Emphysema

Keywords

EmphysemaEndobronchial Lung Volume Reduction

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Until end of study procedure

Secondary Outcomes (1)

  • Technical success

    During procedure and up 1 week post procedure

Study Arms (1)

1

EXPERIMENTAL
Device: Chartis System

Interventions

Chartis SystemDEVICE

Assessment of airway flow and pressure

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hyperexcretive chronic bronchitis or excessive sputum secretion
  • Active pulmonary infection
  • Active asthma or lung hyper-responsiveness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, D-69126, Germany

Location

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Felix Herth, MD

    Thoraxklinik am Universitatsklinikum Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

May 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 22, 2009

Record last verified: 2009-01

Locations

DE(1)