Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot 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?

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 Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema
• Intervention / Treatment: Procedure: bronchoscopic lung volume reduction surgery using endobronchial valve

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gang Hou, MD; Phone Number: 010-84205729; Email: hougangcmu@163.com

Study Locations

• China
  • Beijing
    • BeiJing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Gang Hou, Professor; Phone Number: 13840065481; Email: hougangcmu@163.com
      • Contact: Mingming Deng, Doctor; Phone Number: 18801336854; Email: isdeng1017@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endobronchial valve group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in FEV1 relative to baseline	The patient will undergo lung function tests.	12 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators	The patient will undergo lung function tests.	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.	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.	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.	12 weeks after surgery
Percentage change in SGRQ score relative to baseline	The patient will receive a St.Georges respiratory questionnaire (SGRQ) questionnaire survey.	12 weeks after surgery
Percentage change in mMRC grade relative to baseline	The patient will receive a modified Medical Research Council (mMRC) questionnaire.	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.	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.	12 weeks after surgery

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2024
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
• Other Study ID Numbers: 2024-valve-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No