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CompletedNCT05799352Updated Aug 11, 2025

Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

An interventional study of Endoscopic lung volume reduction in COPD, sponsored by Erasme University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Erasme University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Apr 2019, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Chronic obstructive lung disease (COPD) is a common disease that is frequently complicated by hyperinflation. The resulting increase in lung volume impairs the diaphragmatic function because of a shortening of the diaphragmatic fibers and an increase in the radius of curvature of the diaphragmatic domes. Lung volume reduction surgery (LVRS) has already shown an improvement in diaphragmatic function that could be explained by a change of the diaphragm conformation. More recently, endoscopic lung volume reduction (ELVR) has shown benefits in terms of respiratory function, exercise capacity and quality of life, but the mechanisms of these improvements are poorly understood. Therefore, we aim to evaluate the evolution of the diaphragmatic function and the changes in diaphragmatic conformation after unilateral ELVR.

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Conditions studied

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In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 35 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • valves insertion

Exclusion criteria

Exclusion Criteria:

  • TLVR \< 50 %
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Endoscopic lung volume reduction

    All the patients will have endobronchial valves insertion. We will evaluate before and 3 months after the evolution of the diaphragmatic strength and conformation.

    Device: Endoscopic lung volume reduction

Interventions

  • DeviceEndoscopic lung volume reduction

    a prospective monocentric study on hyperinflated COPD patients without collateral ventilation. Patients were evaluated before and 3 months after unilateral ELVR by transdiaphragmatic pressure (Pdi) measured at the functional residual capacity (FRC) after magnetic phrenic stimulation and by high-resolution computed tomography at the FRC allowing 3D modelling of the diaphragm for measurements of fibers length, length of the zone of apposition and radius of curvature of the diaphragmatic domes.

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What researchers measure

Primary outcomes

  1. Transdiaphragmatic pressure

    evaluate the difference in diaphragmatic function, assessed by the transdiaphragmatic pressure, before and 3 months after unilateral valves setting

    Time frame: before until 3 months after the valves insertion

  2. Diaphragmatic conformation

    evaluate the change of the diaphragm conformation, by measuring diaphragmatic fibers length in several planes, diaphragmatic area and radius of curvature, before and 3 months after unilateral ELVR.

    Time frame: before until 3 months after the valves insertion

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Study locations

1 site
  • Erasme Hospital
    Brussels, Brussels Capital 1070, Belgium
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References and documents

Publications

  • Taton O, Perez-Bogerd S, Van Muylem A, Gevenois PA, Van Hove O, Bondue B, Brenard E, Leduc D. Chest mechanics after endoscopic lung volume reduction: Comparison between responders and non-responders based on dynamic hyperinflation. Respir Med Res. 2025 Nov;88:101194. doi: 10.1016/j.resmer.2025.101194. Epub 2025 Jul 23. PubMed 40763652 ↗
  • Taton O, Gevenois PA, Van Muylem A, Bondue B, Van Laethem S, Leduc D. Improvements of the shape and strength of the diaphragm after endoscopic lung volume reduction. Thorax. 2024 Jul 16;79(8):711-717. doi: 10.1136/thorax-2024-221375. PubMed 38914469 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05799352
Lead sponsor
Erasme University Hospital
Responsible party
Olivier Taton (Doctor, Erasme University Hospital) — Principal investigator
First posted
Apr 5, 2023
Start date
Apr 1, 2019
Primary completion
Jan 30, 2025
Completion
Jan 30, 2025
Last update
Aug 11, 2025

Study contacts

Olivier Taton
principal investigator · Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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