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Bronchoscopic EmphysemA Treatment in THE NetherLands (BREATHE-NL)

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ClinicalTrials.gov Identifier: NCT02815683
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Dirk-Jan Slebos, University Medical Center Groningen

Tracking Information
First Submitted Date June 17, 2016
First Posted Date June 28, 2016
Last Update Posted Date November 4, 2020
Actual Study Start Date September 2016
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2016)
Quality of treatment [ Time Frame: Baseline-30 days ]
Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 23, 2016)
  • Change from baseline in lungfunction at 5 years follow up after treatment. [ Time Frame: Baseline- 5 years ]
    -Change from baseline in lungfunction measured by the bodybox at 5 years follow up.
  • Change from baseline in exercise capacity at 5 years follow up after treatment. [ Time Frame: Baseline- 5 years ]
    -Change from baseline in exercise capacity measured by the 6-minute walk distance test at 5 years follow up.
  • Change from baseline in breathlessness at 5 years follow up after treatment. [ Time Frame: Baseline- 5 years ]
    -Change from baseline in breathlessness measured by the mMRC-scale at 5 years follow up.
  • Change from baseline in health status at 5 years follow up after treatment. [ Time Frame: Baseline- 5 years ]
    -Change from baseline in health status measured by the CAT score at 5 years follow up.
  • The incidence of a pneumothorax after the treatment until 5 years follow up. [ Time Frame: Baseline- 5 year ]
    The number of pneumothoraxes will be recorded between treatment and 5 years follow up.
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 Bronchoscopic EmphysemA Treatment in THE NetherLands
Official Title Bronchoscopic Lung Volume Reduction Treatment in Clinical Practice: Introduction and Implementation in The Netherlands and Evaluation of a National Database
Brief Summary

Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.

Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Detailed Description

Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.

Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Study design: This study is a nationwide, multicenter, observational post-marketing study with long-term follow up (5 years).

Study population: The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

Main study parameters/endpoints:

The main study parameter is the assessment of Target Lung Volume Reduction (TLVR) and correct placement of the valves at CT-scan at 30 days post treatment. This is the most accurate and directly treatment related endpoint which will also be used for quality control.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Condition COPD
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Hartman JE, Klooster K, Ten Hacken NHT, van Dijk M, Slebos DJ. Patient Satisfaction and Attainment of Patient-Specific Goals after Endobronchial Valve Treatment. Ann Am Thorac Soc. 2021 Jan;18(1):68-74. doi: 10.1513/AnnalsATS.202004-342OC.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 23, 2016)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2026
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves.

Exclusion Criteria:

  • There are no exclusion criteria for this study.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Karin Klooster, PhD +31503616161 k.klooster@umcg.nl
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02815683
Other Study ID Numbers BREATHE-NL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dirk-Jan Slebos, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Not Provided
Investigators
Principal Investigator: Dirk-Jan Slebos, MD PhD UMCG
PRS Account University Medical Center Groningen
Verification Date November 2020