EmphysemaDIAMANTNCT04735731
Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment
An observational study of Emphysema, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: The diaphragm is the principal respiratory muscle, which separates the thorax from the abdomen. Hyperinflation of the lung places the diaphragm at a mechanical disadvantage, shortens its operating length and changes the mechanical arrangement of costal and crural components of the diaphragm and consequently… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emphysema
- What is being tested?
- Echography
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jan 2023to 13 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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 one-way valves
- Patient read, understood and signed the Informed Consent Form
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale:
The diaphragm is the principal respiratory muscle, which separates the thorax from the abdomen. Hyperinflation of the lung places the diaphragm at a mechanical disadvantage, shortens its operating length and changes the mechanical arrangement of costal and crural components of the diaphragm and consequently decrease the tension that can be developed and the amount of transdiaphragmatic pressure that can be produced. Reducing the lung hyperinflation could improve the diaphragm function mechanically. One of the treatments to reduces lung hyperinflation is the bronchoscopic treatment using endobronchial valves. To our knowledge the change in diaphragm function after bronchoscopic endobronchial valve treatment was never investigated.
Read more
Objective:
To investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (EBV).
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.
Main study parameters: Change in diaphragm function 6 week after EBV treatment measured by ultrasound. The main outcome will be diaphragm motion (difference between maximum in- and expiration).
- Conditions
- Emphysema
- Being tested
- Echography
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchographyDiagnostic test
Echography of diaphragma and other respiratory muscles
| Study group | Role | What they receive |
|---|---|---|
| EBV-patients | Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves Receives: Diagnostic Test: Echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diaphragm motion measured by ultrasound
Change in diaphragm motion 6 week after EBV treatment measured by ultrasound.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start28 Jan 2023
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735731
- Sponsor's protocol ID
- DIAMANT-study
- Acronym
- DIAMANT
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2021
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared on reasonable request
Publications
Roodenburg SA, Slebos DJ, Ter Haar EAMD, Eikelis N, Nilsen K, Schleurholts E, Kirkness JP, Otvos T, Hartman JE. Endobronchial Valve Treatment Improves Regional Specific Ventilation in the Target Lung. Respiration. 2026;105(3):421-428. doi: 10.1159/000549188. Epub 2025 Oct 30.
PubMed 41166529
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment
- ClinicalTrials.gov ID
- NCT04735731
- Acronym / sponsor ID
- DIAMANT / DIAMANT-study
- Conditions
- Emphysema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 3 Feb 2021 (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:
The diaphragm is the principal respiratory muscle, which separates the thorax from the abdomen. Hyperinflation of the lung places the diaphragm at a mechanical disadvantage, shortens its operating length and changes the mechanical arrangement of costal and crural components of the diaphragm and consequently decrease the tension that can be developed and the amount of transdiaphragmatic pressure that can be produced. Reducing the lung hyperinflation could improve the diaphragm function mechanically. One of the treatments to reduces lung hyperinflation is the bronchoscopic treatment using endobronchial valves. To our knowledge the change in diaphragm function after bronchoscopic endobronchial valve treatment was never investigated.
Objective:
To investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (EBV).
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.
Main study parameters: Change in diaphragm function 6 week after EBV treatment measured by ultrasound. The main outcome will be diaphragm motion (difference between maximum in- and expiration).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBV-patients | – | Diagnostic Test: EchographyPatients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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 one-way valves
- Patient read, understood and signed the Informed Consent Form
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
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 |
|---|---|---|
| EchographyEchography of diaphragma and other respiratory muscles | Diagnostic test | EBV-patients |
Primary outcome
Change in diaphragm motion measured by ultrasound
Time frame: 6 weeks
Change in diaphragm motion 6 week after EBV treatment measured by ultrasound.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 41166529Roodenburg SA, Slebos DJ, Ter Haar EAMD, Eikelis N, Nilsen K, Schleurholts E, Kirkness JP, Otvos T, Hartman JE. Endobronchial Valve Treatment Improves Regional Specific Ventilation in the Target Lung. Respiration. 2026;105(3):421-428. doi: 10.1159/000549188. Epub 2025 Oct 30.
- Individual participant dataSharing planned: Undecided. Data can be shared on reasonable 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. This study is not recruiting at the moment.
Dirk-Jan Slebos, 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 Emphysema, 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: finished, as of the sponsor's last update on 15 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diaphragm motion measured by ultrasound (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735731, which also lists 1 linked publication.
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 15 Feb 2024.