Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium (BEVA)

October 23, 2019 updated by: Wim Janssens, KU Leuven
This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of the current study is to explore the effect of targeted lobar endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent collateral ventilation, on lung function, exercise capacity and physical activity. As a secondary objective, changes in physical activity as result of a 3 month activity coaching program delivered between 3 to 6 months post intervention will be investigated. Exploratory objectives are to extend insight in the clinical characteristics of responders and non-responders and to address relationships between lung function response, physical functioning and its impact on inflammation, skeletal and cardiac function. Furthermore, comparison of the effects on lung function, exercise capacity, quality of life and physical activity between endoscopic lung volume reduction and surgical lung volume reduction will be made.

The study will also explore if treatment response can be optimised by an intermediate evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning of the endobronchial valves will be imposed in case no lober atelectasis is visualised.

.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Flanders
      • Leuven, Flanders, Belgium, 3000
        • Recruiting
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 40 - 75 years
  • Confluent or destructive heterogeneous emphysema on CT
  • Smoking cessation for at least 6m (proven by urinary cotinine levels)
  • FEV1 < 60 %predicted, RV > 150 %predicted, TLC > 90 %predicted
  • RV/TLC ratio ≥ 0.55
  • 6MWD < 450 meter
  • mMRC ≥ 2
  • Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT of referring physician
  • LABA-LAMA bronchodilator therapy as a minimum therapy
  • Able to sign informed consent

Exclusion Criteria:

  • Homogenous emphysema
  • PaCO2 > 60 mmHg with ambient air
  • PaO2 < 45 mmHg with ambient air
  • Previous LVRS, lung transplantation, lobectomy
  • TLCO or FEV1 < 20% predicted
  • Significant pulmonary hypertension (PaPsyst > 50 mm Hg)
  • Heart failure with reduced EF (< 40%)
  • 6MWD < 100 meter
  • BODE index ≥ 7 and eligible for transplantation
  • Active cancer
  • Life expectancy < 3 months
  • Significant lung disease other than COPD/emphysema
  • Unable to comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: control
standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation.
Behavioral: physical activity tele coaching
3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.
Procedure: Lung volume reduction surgery (LVRS)
Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.
Experimental: Endobronchial valves
Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention.
Behavioral: physical activity tele coaching
3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.
Procedure: Lung volume reduction surgery (LVRS)
Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.
Device: endobronchial valves
A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
response rate of FEV1 at 3 months post intervention
Time Frame: 3 months
proportion of patients with a minimal change of FEV1 > 100 ml
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
response rate on SGRQ at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
proportion of patients with a minimal change of -4 points on SGRQ
3 months and 6 months post intervention
response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
proportion of patients with a minimal improvement of 30 meters on 6MWD
3 months and 6 months post intervention
response rate on residual volume (RV) at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
proportion of patients with a minimal reduction of 400 ml on residual volume
3 months and 6 months post intervention
response rate on FEV1 at 6 months post intervention
Time Frame: 6 months
proportion of patients with a minimal change of FEV1 > 100 ml
6 months
response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
proportion of patients with a minimal change of -1 point on TDI
3 months and 6 months post intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
Absolute difference from baseline values (liters)
3 months and 6 months post intervention
Change in RV/TLC ratio (%) at 3 and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
Absolute difference from baseline values (%)
3 months and 6 months post intervention
Change in 6MWD (meters) at 3 and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
Absolute difference from baseline values (meters)
3 months and 6 months post intervention
Change in physical activity at 3 months post intervention
Time Frame: 3 months post intervention
Absolute difference in stepcounts per day (n) from baseline values
3 months post intervention
Change in ProActive clinical visit questionnaire
Time Frame: 3 months post intervention
Absolute difference in points from baseline values
3 months post intervention
Change in BODE index
Time Frame: 3 months and 6 months post intervention
Absolute difference in points from baseline values
3 months and 6 months post intervention
changes in physical activity between 3 and 6 months of follow up (telecoaching period)
Time Frame: 3 months - 6 months post allocation
Absolute difference in stepcounts per day (n) 3 months - 6 months post allocation
3 months - 6 months post allocation
changes in ProActive clinical visit questionnaire between 3 and 6 months of follow up (telecoaching period)
Time Frame: 3 months - 6 months post allocation
Absolute difference in points 3 months - 6 months post allocation
3 months - 6 months post allocation
Comparing change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post EBV and LVRS
Time Frame: 3 months and 6 months post intervention (endoscopic or surgical)
Absolute difference from baseline values (liters) for both interventions
3 months and 6 months post intervention (endoscopic or surgical)
Comparing change in 6MWD at 3 and 6 months post EBV and LVRS
Time Frame: 3 months and 6 months post intervention (endoscopic or surgical)
Absolute difference from baseline values (meters) for both interventions
3 months and 6 months post intervention (endoscopic or surgical)
Comparing change in physical activity at 3 and 6 months post EBV and LVRS
Time Frame: 3 months and 6 months post intervention (endoscopic or surgical)
Absolute difference from baseline values (amount of steps per day) for both interventions
3 months and 6 months post intervention (endoscopic or surgical)
Comparing change in SGRQ at 3 and 6 months post EBV and LVRS
Time Frame: 3 months and 6 months post intervention (endoscopic or surgical)
Absolute difference from baseline values for both interventions
3 months and 6 months post intervention (endoscopic or surgical)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wim Janssens, MD, University Hospital Leuven, Belgium
  • Principal Investigator: Dooms Christophe, MD, University Hospial Leuven, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • s60207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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