NCT06702072 Change in Task-related Oxygen Uptake After EBV Treatment
| NCT ID | NCT06702072 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | COPD |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-06-02 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: 1. Patient is scheduled for a bronchoscopic lung volume treatment using Pulmonx Zephyr Endobronchial Valves; 2. Patient read, understood and signed the Informed Consent Form. Exclusion Criteria: 1\) Patients who cannot perform ADL activities without the use of Long Term Oxygen Therapy (LTOT).
Contact & Investigator
Dirk-Jan Slebos, MD PHD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT06702072 clinical trial?
This trial is open to participants of all sexes, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06702072 currently recruiting?
Yes, NCT06702072 is actively recruiting participants. Contact the research team at j.hartman@umcg.nl for enrollment information.
Where is the NCT06702072 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06702072 clinical trial?
NCT06702072 is sponsored by University Medical Center Groningen. The principal investigator is Dirk-Jan Slebos, MD PHD at University Medical Center Groningen. The trial plans to enroll 20 participants.
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