Introduction of the Vapor Treatment in The Netherlands (NEVEL)

Introduction in the NEtherlands of the Vapor Treatment for Patients With Severe Emphysema: a New Lungvolume Reduction Treatment

Rationale: The bronchoscopic lung volume reduction treatment using vapor was found to be effective and 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. Some of the patients refered to the UMCG 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.

Objective: 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.

Study designThis study will be a prospective observational, single center study. 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.

Study population: Patients with severe COPD who undergo the Thermal Vapor treatment.

Study Overview

• Status: Withdrawn
• Conditions: Emphysema or COPD
• Intervention / Treatment: Other: NA: intervention is not part of the study

Detailed Description

Rationale: 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 refered 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.

Objective: 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.

Study designThis 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.

Study population: Patients with severe COPD who undergo the Thermal Vapor treatment.

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

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with severe COPD who undergo the Thermal Vapor treatment.

Description

Inclusion Criteria:

1. Diagnosis of COPD
2. FEV1%pred <45% and FVC<70%pred,
3. Severe lung hyperinflation: RV>175%pred and RV/TLC>55%
4. Patients will have heterogeneous emphysema, as evidenced by high-resolution CT demonstrating a heterogeneity Index >1.2 in at least one segment to be treated.
5. Nonsmoking for at least 6 months prior to entering the study
6. Completed a pulmonary rehabilitation program within 6 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.
7. Read, understood and signed the Informed Consent form.

Exclusion Criteria:

1. FEV1 < 15% predicted
2. Inability to walk >140 meters in 6 minutes (6MWD) following optimized medical management
3. Subject has a history of recurrent clinically significant respiratory infections, defined as 3 or more hospitalizations for respiratory infection during the year prior to enrolment.
4. Highly diseased lower lobes (tissue to air ratio of <11%)
5. Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
6. Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >45 mm Hg via echocardiogram.
7. Subject has severe gas exchange abnormalities as defined by: PaCO2 >8.0 kPa and/or PaO2 < 6.0 kPa (on room air).
8. Subject has an inability to tolerate bronchoscopy under conscious sedation or general anaesthesia.
9. Subject is taking >5 mg prednisone (or equivalent dose of a similar steroid) daily.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vapor group; Bronchoscopic lung volume reduction treatment using Vapor	Other: NA: intervention is not part of the study; NA: it is not an interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function	Change in Forced Expiratory Volume in 1 second (FEV1)	Between baseline and 6 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety by number of adverse events	Number of all adverse events	Between baseline and 1 year follow up
Lung function	Change in Forced Expiratory Volume in 1 second	Between baseline and 1 year follow up
Hyperinflation	Change in Residual Volume	Between baseline and 6 months follow up
Hyperinflation	Change in Residual Volume	Between baseline and 1 year follow up
Quality of life measured by a questionnaire	Change in St. George's Respiratory Questionnaire (SGRQ) total score (range 0-100, highest indicated worsed quality of life)	Between baseline and 6 months follow up
Quality of life measured by a questionnaire	Change in St. George's Respiratory Questionnaire (SGRQ) total score (range 0-100, highest indicated worsed quality of life)	Between baseline and 1 year follow up
Exercise capacity	Change in 6-minute walk distance (6MWD)	Between baseline and 6 months follow up
Exercise capacity	Change in 6-minute walk distance (6MWD)	Between baseline and 12 months follow up

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Dirk-Jan Slebos, MD PhD, Univeristy Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: NEVEL-study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No