Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema

Heidelberg University

Status: Completed

Conditions: Pulmonary Emphysema

Treatments: Device: IBV implantation; Device: EBV implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01457833

Protokoll E1.0-23.05.2011

Details and patient eligibility

About

Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.

Full description

Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.

Enrollment: 60 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
• heterogeneous emphysema

Exclusion criteria

• homogeneous emphysema
• significant bronchiectasis
• severe concomitant diseases
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Endobronchial valves (EBV)

Active Comparator group

Description:

Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves

Treatment:

Device: EBV implantation

Intrabronchial valves (IBV)

Active Comparator group

Description:

Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves

Treatment:

Device: IBV implantation