Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Spiration, Inc.
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00995852
First received: October 14, 2009
Last updated: April 26, 2011
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Pulmonary Emphysema
Device: IBV Implantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Unilateral vs. Bilateral IBV Placement

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Improvement in pulmonary function (FEV1) 6-minute walking test [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of major complications(SAE) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Evaluation of the IBV migration rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Average changes in quality of life (SGRQ) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bilateral

Treatment arm B - incomplete bilateral treatment of in total two lobes (contralateral).

The study will only use Intrabronchial Valves™

Device: IBV Implantation
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
Other Name: Spiration IBV
Active Comparator: unilateral
Treatment arm A - unilateral treatment with complete closure of the worst lobe of the lungs
Device: IBV Implantation
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
Other Name: Spiration IBV

Detailed Description:

Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. All patients will undergo treatment at one study centre in Heidelberg. Patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (IBV) on the basis of their emphysema distribution. Patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant homogeneous disease FEV1 < 20%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995852

Contacts
Contact: Felix JF Herth, MD +49 6221 396 ext 1200 Felix.Herth@thoraxklinik-heidelberg.de
Contact: Ralf Eberhardt, MD +49 6221 396 ext 1204 Ralf.Eberhardt@rthoraxklinik-heidelberg.de

Locations
Germany
Thoraxklinik Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Felix JF Herth, MD    +49 6221 396 ext 1200    Felix.Herth@thoraxklinik-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Spiration, Inc.
Investigators
Principal Investigator: Felix JF Herth, MD Heidelberg University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Felix JF Herth, Thoraxklinik Heidelberg
ClinicalTrials.gov Identifier: NCT00995852     History of Changes
Other Study ID Numbers: 09 2009
Study First Received: October 14, 2009
Last Updated: April 26, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
Endoscopic lung volume reduction
emphysema
COPD
Patients with bilateral heterogeneous pulmonary emphysema

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014