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

Not Applicable

Completed

• Conditions: Pulmonary Emphysema
• Interventions: Device: EBV implantation; Device: IBV implantation

• Registration Number: NCT01457833
• Lead Sponsor: Heidelberg University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-21
• Study First Posted: 2011-10-24
• Primary Completion: 2012-05-01
• Study Completion: 2012-05-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endobronchial valves (EBV)	EBV implantation	Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves
Intrabronchial valves (IBV)	IBV implantation	Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves

Primary Outcome Measures

Name	Time	Method
Improvement in pulmonary function (FEV1 and RV/TLC)	6 months

Secondary Outcome Measures

Name	Time	Method
Average changes in 6-minute-walk-distance	6 months
Evaluation of valve migration rate	6 months
Number of severe adverse events	6 months
Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)	6 months

Trial Locations

Locations (1)

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany