Change in Task-related Oxygen Uptake After EBV Treatment

NCT06702072 | Recruiting

• 1 other identifier: CROCODILE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; Emphysema; lung volume reduction; endobronchial valves; bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Endobronchial valve treatment

Patients who are undergo a bronchoscopic treatment using endobronchial valves.

Device: Endobronchial valve treatment

Interventions

Endobronchial valve treatment DEVICE

Endobronchial valve treatment

Endobronchial valve treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

You may qualify if:

• Patient is scheduled for a bronchoscopic lung volume treatment using Pulmonx Zephyr Endobronchial Valves;
• Patient read, understood and signed the Informed Consent Form.

You may not qualify if:

• \) Patients who cannot perform ADL activities without the use of Long Term Oxygen Therapy (LTOT).

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk-Jan Slebos, MD PHD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorine E Hartman, PhD

CONTACT

0031503619194; j.hartman@umcg.nl

Marlies van DIjk, MD PhD

CONTACT

0031503619194

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: June 2, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

NL (1)