NCT00995852

Brief Summary

Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

April 27, 2011

Status Verified

October 1, 2009

Enrollment Period

1.7 years

First QC Date

October 14, 2009

Last Update Submit

April 26, 2011

Conditions

Pulmonary Emphysema

Keywords

Endoscopic lung volume reductionemphysemaCOPDPatients with bilateral heterogeneous pulmonary emphysema

Outcome Measures

Primary Outcomes (1)

  • Improvement in pulmonary function (FEV1) 6-minute walking test

    3 months

Secondary Outcomes (4)

  • Number of major complications(SAE)

    3 months

  • Evaluation of the IBV migration rate

    3 months

  • Average changes in quality of life (SGRQ)

    3 months

  • Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)

    3 months

Study Arms (2)

bilateral

ACTIVE COMPARATOR

Treatment arm B - incomplete bilateral treatment of in total two lobes (contralateral). The study will only use Intrabronchial Valves™

Device: IBV Implantation

unilateral

ACTIVE COMPARATOR

Treatment arm A - unilateral treatment with complete closure of the worst lobe of the lungs

Device: IBV Implantation

Interventions

IBV ImplantationDEVICE

In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of "new" air during inspiration

Also known as: Spiration IBV
unilateral

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT \> 150 m

You may not qualify if:

  • pregnant homogeneous disease FEV1 \< 20%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

RECRUITING

Related Publications (4)

  • Venuta F, Rendina EA, Coloni GF. Endobronchial treatment of emphysema with one-way valves. Thorac Surg Clin. 2009 May;19(2):255-60, x. doi: 10.1016/j.thorsurg.2009.04.002.

    PMID: 19662969BACKGROUND

  • Chan KM, Martinez FJ, Chang AC. Nonmedical therapy for chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2009 Jan 15;6(1):137-45. doi: 10.1513/pats.200809-114GO.

    PMID: 19131539BACKGROUND

  • Ingenito EP, Wood DE, Utz JP. Bronchoscopic lung volume reduction in severe emphysema. Proc Am Thorac Soc. 2008 May 1;5(4):454-60. doi: 10.1513/pats.200707-085ET.

    PMID: 18453355BACKGROUND

  • Eberhardt R, Gompelmann D, Schuhmann M, Reinhardt H, Ernst A, Heussel CP, Herth FJF. Complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012 Oct;142(4):900-908. doi: 10.1378/chest.11-2886.

    PMID: 22459779DERIVED

MeSH Terms

Conditions

Pulmonary EmphysemaEmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Felix JF Herth, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix JF Herth, MD

CONTACT

+49 6221 396Felix.Herth@thoraxklinik-heidelberg.de

Ralf Eberhardt, MD

CONTACT

+49 6221 396Ralf.Eberhardt@rthoraxklinik-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

April 27, 2011

Record last verified: 2009-10

Locations

DE(1)