Introduction of the Vapor Treatment in The Netherlands

NCT04029077 | Withdrawn

• 1 other identifier: NEVEL-study
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Emphysema or COPD

Outcome Measures

Primary Outcomes (1)

• Lung function

  Change in Forced Expiratory Volume in 1 second (FEV1)

  Between baseline and 6 months follow up

Secondary Outcomes (8)

• Safety by number of adverse events

  Between baseline and 1 year follow up

• Lung function

  Between baseline and 1 year follow up

• Hyperinflation

  Between baseline and 6 months follow up

• Hyperinflation

  Between baseline and 1 year follow up

• Quality of life measured by a questionnaire

  Between baseline and 6 months follow up

Study Arms (1)

Vapor group

Bronchoscopic lung volume reduction treatment using Vapor

Other: NA: intervention is not part of the study

Interventions

NA: intervention is not part of the study OTHER

NA: it is not an interventional study

Vapor group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe COPD who undergo the Thermal Vapor treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Dirk-Jan Slebos, MD PhD

  Univeristy Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary physician

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 14, 2022

Record last verified: 2022-02