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Tests treatment safety and results for Emphysema
Official title Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
ClinicalTrials.gov ID: NCT06349174
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- 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%;
You likely can't join if
- 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...
- 5\. Coagulation dysfunction, platelet count\<60e+09/L;
- 6\. Myocardial infarction or congestive heart failure within the past 24 weeks;
See the full eligibility criteria
- 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;
- 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.
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.