COPDCROCODILENCT06702072
Change in Task-related Oxygen Uptake After EBV Treatment
An observational study of COPD, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: Bronchoscopic lung volume reduction using endobronchial valves (EBV) has emerged as a viable treatment option for eligible patients with severe emphysema. In all studies conducted so far, exercise capacity has only been measured using the 6-minute walk distance test (6MWT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- Endobronchial valve treatment
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Jun 2025to 1 Aug 2028
- 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: The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Who may be able to join
- Patient is scheduled for a bronchoscopic lung volume treatment using Pulmonx Zephyr Endobronchial Valves;
- Patient read, understood and signed the Informed Consent Form.
Who cannot join
- 1) Patients who cannot perform ADL activities without the use of Long Term Oxygen Therapy (LTOT).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marlies van DIjk, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Jorine E. Hartman, PhD, 0031503619194, j.hartman@umcg.nl
About this study
Official title: Change in Task-related Oxygen Uptake After Bronchoscopic Lung Volume Reduction With Endobronchial Valves
Rationale: Bronchoscopic lung volume reduction using endobronchial valves (EBV) has emerged as a viable treatment option for eligible patients with severe emphysema. In all studies conducted so far, exercise capacity has only been measured using the 6-minute walk distance test (6MWT). It is known that patients with COPD frequently experience problems during ADL, which can lead to avoidance of or care dependency for performing certain tasks and have a significant social impact on their lives.
Patients report that it is easier to perform ADLs after EBV treatment. Previously it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs has never been investigated before.
Read more
Potentially, EBV treatment could improve the metabolic load and consequently symptom perception, thus enhancing the execution of ADLs, which is an important patient-centred outcome. However, this has not been investigated so far.
Objective: To investigate the change in exercise physiology during daily activities after EBV treatment.
Study design: Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves.
Study population: Patients with emphysema who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.
Intervention: Not applicable Main study parameters: The change in task-related oxygen uptake measured with a mobile oxygen device during activities of daily life 6 months after EBV treatment.
Read the detailed description
Rationale: Bronchoscopic lung volume reduction using endobronchial valves (EBV) has emerged as a viable treatment option for eligible patients with severe emphysema. In all studies conducted so far, exercise capacity has only been measured using the 6-minute walk distance test (6MWT). The 6MWT is conducted under laboratory conditions, which weakly correspond to activities of daily living (ADL). It is known that patients with COPD frequently experience problems during ADL, which can lead to avoidance of or care dependency for performing certain tasks and have a significant social impact on their lives.
Patients report that it is easier to perform ADLs after EBV treatment. Previously, it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs was not investigated before. This could be measured with a mobile oxygen device which can measure oxygen uptake (VO2) and carbon dioxide production (VCO2) under more functional conditions and thus measure the metabolic load of these activities.
Potentially, EBV treatment could improve the metabolic load and consequently symptom perception, thus enhancing the execution of ADLs, which is an important patient-centred outcome. However, this has not been investigated so far.
Objective: To investigate the change in exercise physiology during daily activities after EBV treatment.
Study design: Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves.
Study population: Patients with emphysema who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.
Intervention: Not applicable Main study parameters: The change in task-related oxygen uptake measured with a mobile oxygen device during activities of daily life 6 months after EBV treatment.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study has no specific benefits for the participating patients and the study also has no major risks.
- Conditions
- COPD
- Being tested
- Endobronchial valve treatment
- Keywords
- COPD, Emphysema, lung volume reduction, endobronchial valves, bronchoscopy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial valve treatmentDevice
Endobronchial valve treatment
| Study group | Role | What they receive |
|---|---|---|
| Endobronchial valve treatment | Patients who are undergo a bronchoscopic treatment using endobronchial valves. Receives: Device: Endobronchial valve treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task-related oxygen uptake
The change between baseline and 6 months of follow up after EBV treatment in task-related oxygen uptake (VO2) during a set-up daily life activity trail.
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start2 Jun 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk-Jan Slebos, MD PHD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702072
- Sponsor's protocol ID
- CROCODILE
- Acronym
- CROCODILE
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends on the request
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Task-related Oxygen Uptake After Bronchoscopic Lung Volume Reduction With Endobronchial Valves
- ClinicalTrials.gov ID
- NCT06702072
- Acronym / sponsor ID
- CROCODILE / CROCODILE
- Conditions
- COPD
- Keywords
- COPD, Emphysema, lung volume reduction, endobronchial valves, bronchoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 22 Nov 2024 (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: Bronchoscopic lung volume reduction using endobronchial valves (EBV) has emerged as a viable treatment option for eligible patients with severe emphysema. In all studies conducted so far, exercise capacity has only been measured using the 6-minute walk distance test (6MWT). It is known that patients with COPD frequently experience problems during ADL, which can lead to avoidance of or care dependency for performing certain tasks and have a significant social impact on their lives.
Patients report that it is easier to perform ADLs after EBV treatment. Previously it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs has never been investigated before.
Potentially, EBV treatment could improve the metabolic load and consequently symptom perception, thus enhancing the execution of ADLs, which is an important patient-centred outcome. However, this has not been investigated so far.
Objective: To investigate the change in exercise physiology during daily activities after EBV treatment.
Study design: Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves.
Study population: Patients with emphysema who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.
Intervention: Not applicable Main study parameters: The change in task-related oxygen uptake measured with a mobile oxygen device during activities of daily life 6 months after EBV treatment.
Detailed description
Rationale: Bronchoscopic lung volume reduction using endobronchial valves (EBV) has emerged as a viable treatment option for eligible patients with severe emphysema. In all studies conducted so far, exercise capacity has only been measured using the 6-minute walk distance test (6MWT). The 6MWT is conducted under laboratory conditions, which weakly correspond to activities of daily living (ADL). It is known that patients with COPD frequently experience problems during ADL, which can lead to avoidance of or care dependency for performing certain tasks and have a significant social impact on their lives.
Patients report that it is easier to perform ADLs after EBV treatment. Previously, it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs was not investigated before. This could be measured with a mobile oxygen device which can measure oxygen uptake (VO2) and carbon dioxide production (VCO2) under more functional conditions and thus measure the metabolic load of these activities.
Potentially, EBV treatment could improve the metabolic load and consequently symptom perception, thus enhancing the execution of ADLs, which is an important patient-centred outcome. However, this has not been investigated so far.
Objective: To investigate the change in exercise physiology during daily activities after EBV treatment.
Study design: Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves.
Study population: Patients with emphysema who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.
Intervention: Not applicable Main study parameters: The change in task-related oxygen uptake measured with a mobile oxygen device during activities of daily life 6 months after EBV treatment.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study has no specific benefits for the participating patients and the study also has no major risks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endobronchial valve treatment | – | Device: Endobronchial valve treatmentPatients who are undergo a bronchoscopic treatment using endobronchial valves. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Key inclusion criteria (2 listed)
- Patient is scheduled for a bronchoscopic lung volume treatment using Pulmonx Zephyr Endobronchial Valves;
- Patient read, understood and signed the Informed Consent Form.
Key exclusion criteria (1 listed)
- 1) Patients who cannot perform ADL activities without the use of Long Term Oxygen Therapy (LTOT).
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 |
|---|---|---|
| Endobronchial valve treatmentEndobronchial valve treatment | Device | Endobronchial valve treatment |
Primary outcome
Task-related oxygen uptake
Time frame: 6 months follow up
The change between baseline and 6 months of follow up after EBV treatment in task-related oxygen uptake (VO2) during a set-up daily life activity trail.
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 29 Apr 2026.
- Individual participant dataSharing planned: Undecided. Depends on the request
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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.
Marlies van DIjk, MD PhD contact
Dirk-Jan Slebos, MD PHD principal investigator
University Medical Center Groningen
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 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 2 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 29 Apr 2026. 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 Jorine E Hartman, PhD (0031503619194, j.hartman@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task-related oxygen uptake (time frame: 6 months follow up). 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 29 Apr 2026.