NCT01101958

Brief Summary

Use of the Chartis® Assessment System prior to EBV Treatment

Trial Health

90
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

April 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 23, 2014

Completed
Last Updated

May 12, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

April 8, 2010

Results QC Date

December 4, 2013

Last Update Submit

April 6, 2017

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

  • Lung Volume Change

    30 Days

Study Arms (1)

Chartis System-EBV Treatment

OTHER

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).

Device: Chartis SystemDevice: Endobronchial Valve (EBV) Treatment

Interventions

Endobronchial Valve (EBV) TreatmentDEVICE

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

Chartis System-EBV Treatment
Chartis SystemDEVICE

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

Chartis System-EBV Treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Heidelberg

Heidelberg, 69126, Germany

Location

UMC Groningen

Groningen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 22556025DERIVED

MeSH Terms

Conditions

Emphysema

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Prof. Dr. F.J.F. Herth
Organization
ThoraxKlinik, University of Heidelberg
Felix.Herth@thoraxklinik-heidelberg.de
650-216-0176

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 12, 2010

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 12, 2017

Results First Posted

January 23, 2014

Record last verified: 2017-04

Locations

NL(1)DE(1)