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

Primary Purpose

Pulmonary Emphysema

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

EBV implantation

IBV implantation

About this trial

This is an interventional treatment trial for Pulmonary Emphysema

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

homogeneous emphysema
significant bronchiectasis
severe concomitant diseases
pregnancy

Sites / Locations

Thoraxklinik Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Endobronchial valves (EBV)

Intrabronchial valves (IBV)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in pulmonary function (FEV1 and RV/TLC)

Secondary Outcome Measures

Number of severe adverse events

Evaluation of valve migration rate

Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)

Average changes in 6-minute-walk-distance

Full Information

NCT ID

NCT01457833

First Posted

October 19, 2011

Last Updated

July 4, 2022

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT01457833

Brief Title

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

Official Title

Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

May 1, 2012 (Actual)

Study Completion Date

May 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Emphysema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endobronchial valves (EBV)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Intrabronchial valves (IBV)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

EBV implantation

Other Intervention Name(s)

(Zephyr EBV)

Intervention Description

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. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.

Intervention Type

Device

Intervention Name(s)

IBV implantation

Other Intervention Name(s)

(Spiration IBV)

Intervention Description

Primary Outcome Measure Information:

Title

Improvement in pulmonary function (FEV1 and RV/TLC)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Number of severe adverse events

Time Frame

6 months

Title

Evaluation of valve migration rate

Time Frame

6 months

Title

Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)

Time Frame

6 months

Title

Average changes in 6-minute-walk-distance

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 % heterogeneous emphysema Exclusion Criteria: homogeneous emphysema significant bronchiectasis severe concomitant diseases pregnancy

Facility Information:

Facility Name

Thoraxklinik Heidelberg

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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