Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

Unilateral vs. Bilateral IBV Placement

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00995852

Enrollment

Registered

2009-10-15

Start date

2009-09-30

Completion date

2011-05-31

Last updated

2011-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Emphysema

Keywords

Endoscopic lung volume reduction, emphysema, COPD, Patients with bilateral heterogeneous pulmonary emphysema

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.

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.

Interventions

DEVICEIBV 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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* pregnant homogeneous disease FEV1 \< 20%

Design outcomes

Primary

Measure	Time frame
Improvement in pulmonary function (FEV1) 6-minute walking test	3 months

Secondary

Measure	Time frame
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

Countries

Germany

Contacts

Primary ContactFelix JF Herth, MD

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

Backup ContactRalf Eberhardt, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026