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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorChina-Japan Friendship Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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%;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • bronchoscopic lung volume reduction surgery using endobronchial valve

Treatment groups

10 Participants
are divided into 1 treatment group