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Introduction of the Vapor Treatment in The Netherlands (NEVEL)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Emphysema or COPD | Other: NA: intervention is not part of the study |
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 [Patient Registry] |
| Estimated Enrollment : | 24 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Introduction in the NEtherlands of the Vapor Treatment for Patients With Severe Emphysema: a New Lungvolume Reduction Treatment |
| Estimated Study Start Date : | December 1, 2021 |
| Estimated Primary Completion Date : | December 1, 2026 |
| Estimated Study Completion Date : | December 1, 2026 |
| 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
|
- Lung function [ Time Frame: Between baseline and 6 months follow up ]Change in Forced Expiratory Volume in 1 second (FEV1)
- Safety by number of adverse events [ Time Frame: Between baseline and 1 year follow up ]Number of all adverse events
- Lung function [ Time Frame: Between baseline and 1 year follow up ]Change in Forced Expiratory Volume in 1 second
- Hyperinflation [ Time Frame: Between baseline and 6 months follow up ]Change in Residual Volume
- Hyperinflation [ Time Frame: Between baseline and 1 year follow up ]Change in Residual Volume
- Quality of life measured by a questionnaire [ Time Frame: Between baseline and 6 months follow up ]Change in St. George's Respiratory Questionnaire (SGRQ) total score (range 0-100, highest indicated worsed quality of life)
- Quality of life measured by a questionnaire [ Time Frame: Between baseline and 1 year follow up ]Change in St. George's Respiratory Questionnaire (SGRQ) total score (range 0-100, highest indicated worsed quality of life)
- Exercise capacity [ Time Frame: Between baseline and 6 months follow up ]Change in 6-minute walk distance (6MWD)
- Exercise capacity [ Time Frame: Between baseline and 12 months follow up ]Change in 6-minute walk distance (6MWD)
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
| Contact: Jorine Hartman, PhD | +31653619194 | j.hartman@umcg.nl | |
| Contact: Dirk-Jan Slebos, MD PhD | +3165361361 | d.j.slebos@umcg.nl |
| Principal Investigator: | Dirk-Jan Slebos, MD PhD | Univeristy Medical Center Groningen |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 18, 2019 | ||||||||
| First Posted Date | July 23, 2019 | ||||||||
| Last Update Posted Date | April 29, 2021 | ||||||||
| Estimated Study Start Date | December 1, 2021 | ||||||||
| Estimated Primary Completion Date | December 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Lung function [ Time Frame: Between baseline and 6 months follow up ] Change in Forced Expiratory Volume in 1 second (FEV1)
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Introduction of the Vapor Treatment in The Netherlands | ||||||||
| Official Title | Introduction in the NEtherlands of the Vapor Treatment for Patients With Severe Emphysema: a New Lungvolume Reduction Treatment | ||||||||
| Brief 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. 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. |
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| 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. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 5 Years | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with severe COPD who undergo the Thermal Vapor treatment. | ||||||||
| Condition | Emphysema or COPD | ||||||||
| Intervention | Other: NA: intervention is not part of the study
NA: it is not an interventional study
|
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| Study Groups/Cohorts | Vapor group
Bronchoscopic lung volume reduction treatment using Vapor
Intervention: Other: NA: intervention is not part of the study
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
24 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 1, 2026 | ||||||||
| Estimated Primary Completion Date | December 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04029077 | ||||||||
| Other Study ID Numbers | NEVEL-study | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Dirk-Jan Slebos, University Medical Center Groningen | ||||||||
| Study Sponsor | University Medical Center Groningen | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | University Medical Center Groningen | ||||||||
| Verification Date | April 2021 | ||||||||
