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

NCT06349174 | Recruiting

• 1 other identifier: 2024-valve-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 . 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.

Conditions

Emphysema; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Percentage change in FEV1 relative to baseline

  The patient will undergo lung function tests.

  12 weeks after surgery

Secondary Outcomes (8)

• Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators

  12 weeks after surgery

• Percentage change in RV relative to baseline

  12 weeks after surgery

• Percentage change in TLC relative to baseline

  12 weeks after surgery

• Percentage change in DLCO relative to baseline

  12 weeks after surgery

• Percentage change in SGRQ score relative to baseline

  12 weeks after surgery

Study Arms (1)

Endobronchial valve group

EXPERIMENTAL

The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.

Procedure: bronchoscopic lung volume reduction surgery using endobronchial valve

Interventions

bronchoscopic lung volume reduction surgery using endobronchial valve PROCEDURE

The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.

Endobronchial valve group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;
• \. Age range from 40 to 85 years old (including 40 and 85 years old);
• \. BMI ≤ 35kg/m2;
• \. 15% ≤ FEV1% pred ≤ 45%;
• \. TLC\>100% pred, RV\>140% pred, and DLCO/red% ≥ 20%;
• \. 100m ≤ 6WMD ≤ 500m after rehabilitation training;
• \. Quit smoking for more than 4 months;
• \. The evaluation result of pulmonary bypass ventilation function is negative;
• \. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.

You may not qualify if:

• \. Being pregnant or breastfeeding;
• \. PaCO2\>50mmHg and/or PaO2\<45mmHg;
• \. Obvious bronchiectasis or other infectious lung diseases;
• \. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
• \. Coagulation dysfunction, platelet count\<60e+09/L;
• \. Myocardial infarction or congestive heart failure within the past 24 weeks;
• \. Previous lobectomy, LVRS or lung transplantation;
• \. Anticoagulant therapy that cannot be stopped before surgery;
• \. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure\>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;
• \. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
• \. Pulmonary nodules that require intervention;
• \. Patients participating in other clinical trials;
• \. Individuals with other contraindications to bronchial operations;
• \. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Central Study Contacts

Gang Hou, MD

CONTACT

010-84205729; hougangcmu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: April 11, 2024
• Primary Completion: March 20, 2025
• Study Completion: March 31, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)