Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

Heidelberg University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pulmonary Emphysema

Treatments: Device: IBV Implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00995852

09 2009

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

bilateral

Active Comparator group

Description:

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

Treatment:

Device: IBV Implantation

Device: IBV Implantation

unilateral

Active Comparator group

Description:

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

Treatment:

Device: IBV Implantation

Device: IBV Implantation