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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • bronchoscopic lung volume reduction surgery using endobronchial valve

    Procedure/Surgery

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Endobronchial valve groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change in FEV1 relative to baseline

The patient will undergo lung function tests.

Time frame
12 weeks after surgery

Secondary outcomes

1

Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators

The patient will undergo lung function tests.

Time frame
12 weeks after surgery
2

Percentage change in RV relative to baseline

The patient will undergo lung function tests, and residual volume (RV) will be recorded.

Time frame
12 weeks after surgery
3

Percentage change in TLC relative to baseline

The patient will undergo lung function tests, and total lung capacity (TLC) will be recorded.

Time frame
12 weeks after surgery
4

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.

Time frame
12 weeks after surgery

Other outcomes

Sponsors and contacts

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