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

NCT01457833 | Completed

• 1 other identifier: Protokoll E1.0-23.05.2011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Emphysema

Outcome Measures

Primary Outcomes (1)

• Improvement in pulmonary function (FEV1 and RV/TLC)

  6 months

Secondary Outcomes (4)

• Number of severe adverse events

  6 months

• Evaluation of valve migration rate

  6 months

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

  6 months

• Average changes in 6-minute-walk-distance

  6 months

Study Arms (2)

Endobronchial valves (EBV)

ACTIVE COMPARATOR

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

Device: EBV implantation

Intrabronchial valves (IBV)

ACTIVE COMPARATOR

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

Device: IBV implantation

Interventions

EBV implantation DEVICE

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.

Also known as: (Zephyr EBV)

Endobronchial valves (EBV)

IBV implantation DEVICE

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.

Also known as: (Spiration IBV)

Intrabronchial valves (IBV)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

Location

MeSH Terms

Conditions

Pulmonary Emphysema

Condition Hierarchy (Ancestors)

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 24, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

DE (1)