Bronchoscopic EmphysemA Treatment in THE NetherLands

  • STATUS
    Recruiting
  • End date
    Sep 27, 2026
  • participants needed
    500
  • sponsor
    University Medical Center Groningen
Updated on 27 January 2021
pulmonary function test
emphysema
lung volume reduction

Summary

Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.

Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Description

Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.

Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Study design: This study is a nationwide, multicenter, observational post-marketing study with long-term follow up (5 years).

Study population: The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

Main study parameters/endpoints:

The main study parameter is the assessment of Target Lung Volume Reduction (TLVR) and correct placement of the valves at CT-scan at 30 days post treatment. This is the most accurate and directly treatment related endpoint which will also be used for quality control.

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease), Reactive Airway Disease, chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease (copd)
Clinical Study IdentifierNCT02815683
SponsorUniversity Medical Center Groningen
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have Chronic Obstructive Lung Disease?
Do you have any of these conditions: chronic obstructive pulmonary disease or chronic obstructive pulmonary disease (copd) or Chronic Obstructive Lung Disease or COPD or COPD (Chronic Obs...?
Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves

Exclusion Criteria

There are no exclusion criteria for this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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