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Biological Investigation of Explanted Endobronchial Lung Valves Study (Bio-EXCEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04214587
Recruitment Status : Not yet recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Dirk-Jan Slebos, University Medical Center Groningen

Brief Summary:

Rationale:

COPD is a severe, often progressive and currently incurable lung disease which affects both the upper airways (chronic bronchitis) as well as the lower airways (emphysema). In advanced stages of the disease air-trapping severely reduces the ability to breathe and subsequently the quality of life. A highly effective treatment for restoring lung mechanical functionality of these patients is the introduction of bronchoscopic lung volume reduction (BLVR), e.g. implanting small silicone/nitinol valves (EBV) inside the airways to reduce air-trapping. Although successfully investigated in a selected group of severe COPD patients, the effectiveness of the treatment can sometimes be short-lived due to fibrotic and granulation responses and tissue-material interactions.

Objective:

The main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of BELVR treatment with EBVs, this to investigate the mechanism of action of tissue-device interactions.


Condition or disease Intervention/treatment
Emphysema or COPD Diagnostic Test: tissue and blood sampling

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 2, 2022
Estimated Study Completion Date : March 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Group/Cohort Intervention/treatment
baseline assessment group
n=150 patiënts for baseline assessment
Diagnostic Test: tissue and blood sampling
only diagnostics will be peformed

clinical need for reintervention group
n=20-30 patiënts for re-bronchoscopy
Diagnostic Test: tissue and blood sampling
only diagnostics will be peformed

clinical stable controls
n=20 stable treated control patiënts
Diagnostic Test: tissue and blood sampling
only diagnostics will be peformed




Primary Outcome Measures :
  1. the % of the 150 patients that will develop a need for rebronchoscopy after 18 months [ Time Frame: 18 months ]
    frequency


Biospecimen Retention:   Samples With DNA
epithial brushings blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Severe emphysema patients routinely scheduled for bronchoscopic lung volume reduction with one-way endobronchial valves
Criteria

Inclusion Criteria:

  • Elidgible for EBV treatment

Exclusion Criteria:

  • Anticoagulation which cannot be stopped prior to the procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04214587


Contacts
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Contact: Dirk-Jan Slebos, MD PhD +31503616161 d.j.slebos@umcg.nl
Contact: Jorine Hartman, PhD j.hartman@umcg.nl

Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Dirk-Jan Slebos, MD PhD UMC-Groningen/NL

Additional Information:
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Responsible Party: Dirk-Jan Slebos, Prof. dr. D.J. Slebos MD, PhD, Principle Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04214587    
Other Study ID Numbers: Version 1.0, date 01-01-2020
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emphysema
Pathologic Processes