Emphysema or COPDBio-EXCELNCT04214587
Biological Investigation of Explanted Endobronchial Lung Valves Study
An observational study of Emphysema or COPD, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emphysema or COPD
- What is being tested?
- tissue and blood sampling
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Mar 2021to 2 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Severe emphysema patients routinely scheduled for bronchoscopic lung volume reduction with one-way endobronchial valves
Who may be able to join
- Elidgible for EBV treatment
Who cannot join
- Anticoagulation which cannot be stopped prior to the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jorine Hartman, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Dirk-Jan Slebos, PhD
About this study
Official title: Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions
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.
Read more
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.
- Conditions
- Emphysema or COPD
- Being tested
- tissue and blood sampling
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue and blood samplingDiagnostic test
only diagnostics will be peformed
| Study group | Role | What they receive |
|---|---|---|
| baseline assessment group | n=150 patiënts for baseline assessment Receives: Diagnostic Test: tissue and blood sampling | |
| clinical need for reintervention group | n=20-30 patiënts for re-bronchoscopy Receives: Diagnostic Test: tissue and blood sampling | |
| clinical stable controls | n=20 stable treated control patiënts Receives: Diagnostic Test: tissue and blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
the % of the 150 patients that will develop a need for rebronchoscopy after 18 months
frequency
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start16 Mar 2021
- Primary completion2 Mar 2027 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emphysema or COPDStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, MD PhD, Principal investigator, UMC-Groningen/NL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214587
- Sponsor's protocol ID
- Bio-EXCEL
- Acronym
- Bio-EXCEL
- Status last verified
- Jun 2024
- First submitted
- 27 Dec 2019
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions
- ClinicalTrials.gov ID
- NCT04214587
- Acronym / sponsor ID
- Bio-EXCEL / Bio-EXCEL
- Conditions
- Emphysema or COPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 2 Mar 2027 (estimated)
- Study completion
- 2 Mar 2027 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| baseline assessment group | – | Diagnostic Test: tissue and blood samplingn=150 patiënts for baseline assessment |
| clinical need for reintervention group | – | Diagnostic Test: tissue and blood samplingn=20-30 patiënts for re-bronchoscopy |
| clinical stable controls | – | Diagnostic Test: tissue and blood samplingn=20 stable treated control patiënts |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Severe emphysema patients routinely scheduled for bronchoscopic lung volume reduction with one-way endobronchial valves
Key inclusion criteria (1 listed)
- Elidgible for EBV treatment
Key exclusion criteria (1 listed)
- Anticoagulation which cannot be stopped prior to the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue and blood samplingonly diagnostics will be peformed | Diagnostic test | baseline assessment group, clinical need for reintervention group, clinical stable controls |
Primary outcome
the % of the 150 patients that will develop a need for rebronchoscopy after 18 months
Time frame: 18 months
frequency
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- The UMC-Groningen/NL Bronchoscopic Intervention Center websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorine Hartman, PhD contact
Dirk-Jan Slebos, MD PhD principal investigator
UMC-Groningen/NL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emphysema or COPD, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dirk-Jan Slebos, MD PhD (+31503616161, d.j.slebos@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the % of the 150 patients that will develop a need for rebronchoscopy after 18 months (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.