EmphysemaNCT06349174
Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
A study testing bronchoscopic lung volume reduction surgery using endobronchial valve in people with Emphysema and Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Emphysema, Chronic Obstructive Pulmonary Disease
- What is being tested?
- bronchoscopic lung volume reduction surgery using endobronchial valve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;
- 2. Age range from 40 to 85 years old (including 40 and 85 years old);
- 3. BMI ≤ 35kg/m2;
- 4. 15% ≤ FEV1% pred ≤ 45%;
- 5. TLC>100% pred, RV>140% pred, and DLCO/red% ≥ 20%;
- 6. 100m ≤ 6WMD ≤ 500m after rehabilitation training;
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- 7. Quit smoking for more than 4 months;
- 8. The evaluation result of pulmonary bypass ventilation function is negative;
- 9. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.
Who cannot join
- 1. Being pregnant or breastfeeding;
- 2. PaCO2>50mmHg and/or PaO2<45mmHg;
- 3. Obvious bronchiectasis or other infectious lung diseases;
- 4. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
- 5. Coagulation dysfunction, platelet count<60e+09/L;
- 6. Myocardial infarction or congestive heart failure within the past 24 weeks;
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- 7. Previous lobectomy, LVRS or lung transplantation;
- 8. Anticoagulant therapy that cannot be stopped before surgery;
- 9. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;
- 10. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
- 11. Pulmonary nodules that require intervention;
- 12. Patients participating in other clinical trials;
- 13. Individuals with other contraindications to bronchial operations;
- 14. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Gang Hou, Professor, 13840065481, hougangcmu@163.com
Mingming Deng, Doctor, 18801336854, isdeng1017@163.com
About this study
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?
Read more
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.
- Conditions
- Emphysema, Chronic Obstructive Pulmonary Disease
- Being tested
- bronchoscopic lung volume reduction surgery using endobronchial valve
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopic lung volume reduction surgery using endobronchial valveProcedure or surgery
The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.
| Study group | Role | What they receive |
|---|---|---|
| Endobronchial valve group | Experimental | The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve. Receives: Procedure: bronchoscopic lung volume reduction surgery using endobronchial valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in FEV1 relative to baseline
The patient will undergo lung function tests.
Measured: 12 weeks after surgery
Secondary outcomes (8)
Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators
The patient will undergo lung function tests.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks after surgery
Percentage change in SGRQ score relative to baseline
The patient will receive a St.Georges respiratory questionnaire (SGRQ) questionnaire survey.
Measured: 12 weeks after surgery
Percentage change in mMRC grade relative to baseline
The patient will receive a modified Medical Research Council (mMRC) questionnaire.
Measured: 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.
Measured: 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.
Measured: 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start11 Apr 2024
- Primary completion20 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349174
- Sponsor's protocol ID
- 2024-valve-1
- Status last verified
- Feb 2025
- First submitted
- 31 Mar 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT06349174
- Acronym / sponsor ID
- 2024-valve-1
- Conditions
- Emphysema, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 5 Apr 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endobronchial valve group | Experimental | Procedure: bronchoscopic lung volume reduction surgery using endobronchial valveThe patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;
- 2. Age range from 40 to 85 years old (including 40 and 85 years old);
- 3. BMI ≤ 35kg/m2;
- 4. 15% ≤ FEV1% pred ≤ 45%;
- 5. TLC>100% pred, RV>140% pred, and DLCO/red% ≥ 20%;
Key exclusion criteria (14 listed)
- 1. Being pregnant or breastfeeding;
- 2. PaCO2>50mmHg and/or PaO2<45mmHg;
- 3. Obvious bronchiectasis or other infectious lung diseases;
- 4. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
- 5. Coagulation dysfunction, platelet count<60e+09/L;
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 |
|---|---|---|
| bronchoscopic lung volume reduction surgery using endobronchial valveThe patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve. | Procedure or surgery | Endobronchial valve group |
Primary outcome
Percentage change in FEV1 relative to baseline
Time frame: 12 weeks after surgery
The patient will undergo lung function tests.
8 secondary outcomes
Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators
Time frame: 12 weeks after surgery
Percentage change in RV relative to baseline
Time frame: 12 weeks after surgery
Percentage change in TLC relative to baseline
Time frame: 12 weeks after surgery
Percentage change in DLCO relative to baseline
Time frame: 12 weeks after surgery
Percentage change in SGRQ score relative to baseline
Time frame: 12 weeks after surgery
Percentage change in mMRC grade relative to baseline
Time frame: 12 weeks after surgery
Percentage change in 6MWD relative to baseline
Time frame: 12 weeks after surgery
the incidence of surgical-related adverse events
Time frame: 12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchoscopic lung volume reduction surgery using endobronchial valve in people with Emphysema and Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Hou, MD (010-84205729, hougangcmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in FEV1 relative to baseline (time frame: 12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025.