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Completed

NCT Number: NCT01457833

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

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

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: (Zephyr 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.

Other names: (Spiration IBV)

Primary outcomes

  1. Improvement in pulmonary function (FEV1 and RV/TLC)

    Time frame: 6 months

Secondary outcomes

  1. Number of severe adverse events

    Time frame: 6 months

  2. Evaluation of valve migration rate

    Time frame: 6 months

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

    Time frame: 6 months

  4. Average changes in 6-minute-walk-distance

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 24, 2011
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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