Japanese Registry of Endobronchial Valve Treatment in Severe COPD with Emphysema (The ENHANCE registry)

Japanese Registry of Endobronchial Valve Treatment in Severe COPD with Emphysema (The ENHANCE registry) - The ENHANCE registry

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057491

Enrollment

140

Registered

2025-05-01

Start date

2025-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe emphysematous chronic obstructive pulmonary disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who underwent bronchoscopic lung volume reduction using a bronchial valve system, completed a one-year post-marketing surveillance study, and provided consent to participate in this study.

Exclusion criteria

Exclusion criteria: Patients who could not consent to the study

Design outcomes

Primary

Measure	Time frame
Percentage of patients with a 15% or greater improvement rate in forced expiratory volume in one second after inhalation of bronchodilators 2 to 5 years after EBV treatment Improvement rate = (forced expiratory volume in one second after inhalation of bronchodilators before treatment - forced expiratory volume in one second after inhalation of bronchodilators after treatment) / (forced expiratory volume in one second after inhalation of bronchodilators before treatment)	—

Measure

Time frame

Percentage of patients with a 15% or greater improvement rate in forced expiratory volume in one second after inhalation of bronchodilators 2 to 5 years after EBV treatment Improvement rate = (forced expiratory volume in one second after inhalation of bronchodilators before treatment - forced expiratory volume in one second after inhalation of bronchodilators after treatment) / (forced expiratory volume in one second after inhalation of bronchodilators before treatment)

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Secondary

Measure	Time frame
1. Efficacy outcomes Degree of improvement in the following indicators 2 to 5 years after EBV placement compared to before treatment SGRQ, 6-minute walk, BODE index, blood gas (room air), MMRC, echocardiographic findings, pulmonary function tests after bronchodilator inhalation (forced vital capacity, forced expiratory volume in one second, residual volume, inspiratory reserve, total lung capacity, functional residual capacity, pulmonary diffusion capacity), degree of volume reduction in the target lung lobe compared to before treatment by CT, and proportion of patients observed to have a volume reduction of 350 ml or more 2. Safety outcomes Data on adverse events will be collected for the post-treatment period of 2 to 5 years after treatment. (1)Major adverse events: death, pneumothorax, respiratory failure, pneumonia, COPD exacerbation, one-way valve prolapse, severe bronchial deformation (2)Number of transbronchial interventions (observation, EBV removal, EBV re-insertion, etc.)	—

Measure

Time frame

1. Efficacy outcomes Degree of improvement in the following indicators 2 to 5 years after EBV placement compared to before treatment SGRQ, 6-minute walk, BODE index, blood gas (room air), MMRC, echocardiographic findings, pulmonary function tests after bronchodilator inhalation (forced vital capacity, forced expiratory volume in one second, residual volume, inspiratory reserve, total lung capacity, functional residual capacity, pulmonary diffusion capacity), degree of volume reduction in the target lung lobe compared to before treatment by CT, and proportion of patients observed to have a volume reduction of 350 ml or more 2. Safety outcomes Data on adverse events will be collected for the post-treatment period of 2 to 5 years after treatment. (1)Major adverse events: death, pneumothorax, respiratory failure, pneumonia, COPD exacerbation, one-way valve prolapse, severe bronchial deformation (2)Number of transbronchial interventions (observation, EBV removal, EBV re-insertion, etc.)

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Countries

Japan

Contacts

Public ContactMasamichi Mineshita

St. Marianna University School of Medicine Department of Respiratory Medicine

m-mine@marianna-u.ac.jp0449778111

Outcome results