Emphysema or COPDNEVELNCT04029077
Introduction of the Vapor Treatment in The Netherlands
An observational study of Emphysema or COPD, run by University Medical Center Groningen.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emphysema or COPD
- What is being tested?
- NA: intervention is not part of the study
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe COPD who undergo the Thermal Vapor treatment.
Who may be able to join
- Diagnosis of COPD
- FEV1%pred <45% and FVC<70%pred,
- Severe lung hyperinflation: RV>175%pred and RV/TLC>55%
- 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.
- Nonsmoking for at least 6 months prior to entering the study
- 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.
- Read, understood and signed the Informed Consent form.
Who cannot join
- FEV1 < 15% predicted
- Inability to walk >140 meters in 6 minutes (6MWD) following optimized medical management
- 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.
- Highly diseased lower lobes (tissue to air ratio of <11%)
- Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
- Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >45 mm Hg via echocardiogram.
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- Subject has severe gas exchange abnormalities as defined by: PaCO2 >8.0 kPa and/or PaO2 < 6.0 kPa (on room air).
- Subject has an inability to tolerate bronchoscopy under conscious sedation or general anaesthesia.
- Subject is taking >5 mg prednisone (or equivalent dose of a similar steroid) daily.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Emphysema or COPD
- Being tested
- NA: intervention is not part of the study
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA: intervention is not part of the studyOther
NA: it is not an interventional study
| Study group | Role | What they receive |
|---|---|---|
| Vapor group | Bronchoscopic lung volume reduction treatment using Vapor Receives: Other: NA: intervention is not part of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Change in Forced Expiratory Volume in 1 second (FEV1)
Measured: Between baseline and 6 months follow up
Secondary outcomes (8)
Safety by number of adverse events
Number of all adverse events
Measured: Between baseline and 1 year follow up
Lung function
Change in Forced Expiratory Volume in 1 second
Measured: Between baseline and 1 year follow up
Hyperinflation
Change in Residual Volume
Measured: Between baseline and 6 months follow up
Hyperinflation
Change in Residual Volume
Measured: 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)
Measured: 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)
Measured: Between baseline and 1 year follow up
Exercise capacity
Change in 6-minute walk distance (6MWD)
Measured: Between baseline and 6 months follow up
Exercise capacity
Change in 6-minute walk distance (6MWD)
Measured: Between baseline and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: COVID-19 and other treatments available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emphysema or COPDStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, MD PhD, Principal investigator, Univeristy Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029077
- Sponsor's protocol ID
- NEVEL-study
- Acronym
- NEVEL
- Status last verified
- Feb 2022
- First submitted
- 18 Jul 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only on request
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction in the NEtherlands of the Vapor Treatment for Patients With Severe Emphysema: a New Lungvolume Reduction Treatment
- ClinicalTrials.gov ID
- NCT04029077
- Acronym / sponsor ID
- NEVEL / NEVEL-study
- Conditions
- Emphysema or COPD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID-19 and other treatments available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vapor group | – | Other: NA: intervention is not part of the studyBronchoscopic lung volume reduction treatment using Vapor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe COPD who undergo the Thermal Vapor treatment.
Key inclusion criteria (7 listed)
- Diagnosis of COPD
- FEV1%pred <45% and FVC<70%pred,
- Severe lung hyperinflation: RV>175%pred and RV/TLC>55%
- 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.
- Nonsmoking for at least 6 months prior to entering the study
Key exclusion criteria (9 listed)
- FEV1 < 15% predicted
- Inability to walk >140 meters in 6 minutes (6MWD) following optimized medical management
- 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.
- Highly diseased lower lobes (tissue to air ratio of <11%)
- Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA: intervention is not part of the studyNA: it is not an interventional study | Other | Vapor group |
Primary outcome
Lung function
Time frame: Between baseline and 6 months follow up
Change in Forced Expiratory Volume in 1 second (FEV1)
8 secondary outcomes
Safety by number of adverse events
Time frame: Between baseline and 1 year follow up
Lung function
Time frame: Between baseline and 1 year follow up
Hyperinflation
Time frame: Between baseline and 6 months follow up
Hyperinflation
Time frame: Between baseline and 1 year follow up
Quality of life measured by a questionnaire
Time frame: Between baseline and 6 months follow up
Quality of life measured by a questionnaire
Time frame: Between baseline and 1 year follow up
Exercise capacity
Time frame: Between baseline and 6 months follow up
Exercise capacity
Time frame: Between baseline and 12 months follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Undecided. Only on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk-Jan Slebos, MD PhD principal investigator
Univeristy Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
An observational study of Emphysema or COPD, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: Between baseline and 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.