Change in Task-related Oxygen Uptake After EBV Treatment
CROCODILE
CROCODILE
Sponsor study identifier
observational
20
1 country
1
Study Start
June 2, 2025
Actual (reported)Primary Completion
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 20, 2024
Actual (reported)November 22, 2024
Actual (reported)June 2, 2025
Actual (reported)August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
6 months follow up
Patients who are undergo a bronchoscopic treatment using endobronchial valves.
Endobronchial valve treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Dirk-Jan Slebos, MD PHD
University Medical Center Groningen
First Submitted
November 20, 2024
First Posted
November 22, 2024
Study Start
June 2, 2025
Actual (reported)Primary Completion
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD
Contact the study team to confirm eligibility.
Study Completion
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 29, 2026
Record last verified: 2026-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: