Introduction in the NEtherlands of the Vapor treatment for patients with severe Emphysema: a new Lungvolume reduction treatment

The STEP-UP trial investigated the bronchoscopic lung volume reduction
treatment using vapor and showed that the treatment group significantly
improved after 6 months compared to the control group in Lung function and
quality of life. The authors also concluded that the treatment has an
acceptable safety profile. The results of this trial has led to the inclusion
of this treatment in the COPD GOLD guidelines in 2019. In the Netherlands the
treatment has not been performed so far but the treatment device has been made
available to the UMCG hospital to perform emphysema treatments. Yearly,
approximately 600 severe emphysema patients are referred to the UMCG for a
bronchoscopic treatment but only approximately 10% is suitable for a treatment
with endobronchial valves or coils. Some of the other patients could benefit
from the Vapor treatment and therefore with this treatment we will be able to
treat patients who have no other treatment options left.

The overall aim of this study is to gain experience with the Thermal Vapor
treatment by investigating the safety and efficacy of the treatment.

Primary Objective:
The primary objective is to investigate the change in Lung function (measured
by Forced Expiratory Volume in 1 second (FEV1)) between baseline and 6 months
after the Thermal Vapor treatment.

Secondary Objectives:
Safety
* A secondary objective is to investigate the safety of the Thermal Vapor
treatment by recoding all the adverse events that occur between baseline and 1
year follow up after treatment.
Efficacy
* A secondary objective is to investigate the change in Lung function, lung
hyperinflation, quality of life, dyspnea, CT parameters and exercise capacity
between baseline and 6 and 12 months follow up after treatment.
Longterm
* A secondary objective is to investigate the long term effect of the treatment
in terms of change in Lung function, lung hyperinflation, quality of life and
exercise capacity between baseline and up to 5 years follow up after treatment.

This study will be a prospective observational, single center study that will
investigate the safety and efficacy of the InterVapor (Bronchoscopic Thermal
Vapor Ablation System) that will be introduced in the Netherlands for the first
time. All patients that undergo the bronchoscopic lung volume reduction
treatment using thermal Vapor will be asked if their data can be captured in
the database.

The extra tests that will be performed as part of this study are 1 low dose CT
scan and 2 times peripheral blood collection and bronchial wash collection
before treatment(s) and all data will be registered in a database to be able to
evaluate the efficacy and safety of the treatment. These are procedures for
which the risks are low.