An interventional study of bronchoscopic lung volume reduction surgery using endobronchial valve in Emphysema and Chronic Obstructive Pulmonary Disease, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment
The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:
Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?
Participants will:
undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.
receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 245 interventional studies indexed under Emphysema.
Browse Emphysema studies →China-Japan Friendship Hospital is the lead sponsor of 178 studies on the registry; 111 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.
Procedure: bronchoscopic lung volume reduction surgery using endobronchial valve
The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.
Percentage change in FEV1 relative to baseline
The patient will undergo lung function tests.
Time frame: 12 weeks after surgery
Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators
The patient will undergo lung function tests.
Time frame: 12 weeks after surgery
Percentage change in RV relative to baseline
The patient will undergo lung function tests, and residual volume (RV) will be recorded.
Time frame: 12 weeks after surgery
Percentage change in TLC relative to baseline
The patient will undergo lung function tests, and total lung capacity (TLC) will be recorded.
Time frame: 12 weeks after surgery
Percentage change in DLCO relative to baseline
The patient will undergo lung function tests, and the diffusing capacity for carbon monoxide (DLCO) will be recorded.
Time frame: 12 weeks after surgery
Percentage change in SGRQ score relative to baseline
The patient will receive a St.Georges respiratory questionnaire (SGRQ) questionnaire survey.
Time frame: 12 weeks after surgery
Percentage change in mMRC grade relative to baseline
The patient will receive a modified Medical Research Council (mMRC) questionnaire.
Time frame: 12 weeks after surgery
Percentage change in 6MWD relative to baseline
The patient will undergo 6-minute walk test, and 6-minute walk distance (6MWD) will be recored.
Time frame: 12 weeks after surgery
the incidence of surgical-related adverse events
The surgical-related adverse events refers to pneumothorax, valve displacement or shedding, granuloma formation and other surgical-related adverse events.
Time frame: 12 weeks after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Mar 2025, 11 months after the start.
Of 40 non-industry interventional studies with no phase under Emphysema, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 58. This study's planned 11 months is below that.
Counting every sponsor, half of 60 studies reached it within 37 months; a quarter within 22 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
China-Japan Friendship Hospital →