NCT06163131 The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
| NCT ID | NCT06163131 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aarhus University Hospital |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2026-11-27 |
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 35 participants in total. It began in 2023-11-27 with a primary completion date of 2026-11-27.
⚠ 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
In some patients with chronic obstructive pulmonary disease (COPD) the breathlessness is caused by hyperinflation of the lungs. This causes difficulty breathing air out and makes it harder to breath in new air and limits the movement of the diaphram. The diaphragm is the muscle used for breathing between the chest and the stomach. Some of these patients can receive treatment with endobronchial valves, where one-ways are inserted into the bronchial system the let out some of the excess air, and thereby relieve breathlessness. The goal of this observational study is to investigate the effect of endobronchial valves on the mobility of the diaphragm in patients with chronic obstructive pulmonary disease. The main questions it aims to answer are: * If the movement of the diaphragm improves after treatment with endobronchial valves. * If there is a link between improvement of diaphragm function and improvement of symptoms, lung function and physical ability. * If ultrasound scan immediately after the treatment will predict which patients will benefit from the treatment. Participants will undergo ultrasound before, 1 day after and 90 days after the procedure, and lung function examinations from their already planned control visits will be collected.
Eligibility Criteria
Inclusion Criteria: 1. Patients selected to receive treatment with endobronchial valves 2. Signed informed consent Exclusion Criteria: 1. Neuromuscular disease interfering with diaphragm function 2. Pleural effusion at time of preoperative or 90-days postoperative ultrasound
Frequently Asked Questions
Who can join the NCT06163131 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06163131 currently recruiting?
Yes, NCT06163131 is actively recruiting participants. Visit ClinicalTrials.gov or contact Aarhus University Hospital to inquire about joining.
Where is the NCT06163131 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT06163131 clinical trial?
NCT06163131 is sponsored by Aarhus University Hospital. The trial plans to enroll 35 participants.