UMIN-CTR Clinical Trial

Public title

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

Acronym

The ENHANCE registry

Scientific Title

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

Scientific Title:Acronym

The ENHANCE registry

Region

Japan

Condition

Severe emphysematous chronic obstructive pulmonary disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the long-term efficacy and adverse events associated with bronchoscopic lung volume reduction (BLVR) using the Endobronchial Valve System (EBV) by observing patients for 5 years after treatment.

Basic objectives2

Others

Basic objectives -Others

The information obtained will be analyzed for exploratory purposes to improve treatment outcomes.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase IV

Primary outcomes

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)

Key secondary outcomes

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.)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key exclusion criteria

Patients who could not consent to the study

Target sample size

140

Name of lead principal investigator

1st name	Masamichi
Middle name
Last name	Mineshita

Organization

St. Marianna University School of Medicine

Division name

Department of Respiratory Medicine

Zip code

2168511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa

TEL

0449778111

Email

m-mine@marianna-u.ac.jp

Name of contact person

1st name	Masamichi
Middle name
Last name	Mineshita

Organization

St. Marianna University School of Medicine

Division name

Department of Respiratory Medicine

Zip code

2168511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa

TEL

0449778111

Homepage URL

Email

m-mine@marianna-u.ac.jp

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Masamichi Mineshita

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Ethical Committee for Clinical Studies at St. Marianna University School of Medicine

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa

Tel

0449778111

Email

k-sienbu.mail@marianna-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2025

Year

04

Month

02

Day

Date of IRB

2025

Year

04

Month

02

Day

Anticipated trial start date

2025

Year

05

Month

01

Day

Last follow-up date

2032

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Use the following information obtained during medical examinations, etc.
(1) Vital status, medical condition, BMI, etc.
(2) Various respiratory function tests (after bronchodilator inhalation)
(3) 6-minute walk
(4) Cardiac function tests (electrocardiogram, transthoracic echocardiogram)
(5) Chest CT
(6) Blood gases
(7) Questionnaire test (SGRQ score (Japanese version license to be obtained), mMRC score)
(8) Confirmation of adverse events, for fatal cases, information such as the date of death, whether or not it was due to a respiratory disease, and whether it was related to bronchial valve treatment will also be collected.

2. Methods
(1)Patient Registration and Sending of CT Data
- The serial number of each study facility (hereafter abbreviated as facility serial number) for patient verification will be the same as the number used in the post-marketing surveillance.
- Each study facility will create a document that allows patients to verify the facility serial number and store it in a locked room or cupboard.
- Each study facility will mail a CD of HRCT DICOM data with the facility name, facility serial number, and facility serial number without personal information to Pulmonx Japan.
- The HRCT data will be analyzed by Pulmonx Japan using the imaging software StratX Lung Analysis Platform (hereafter abbreviated as StratX), and the analysis results will be provided to the secretariat and the facility with the facility serial number added.
(2)Data registration
- The data obtained will be entered into the EDC (Electronic Data Capture) at each research facility. The EDC will be created by the St. Marianna University School of Medicine Clinical Research Data Center.
- For deaths, details such as the date of death, whether or not it was due to respiratory disease, and the relevance of bronchial valve treatment will be entered in the "5) Details of reasons for discontinuation" column of the CRF.

Registered date

2025

Year

04

Month

02

Day

Last modified on

2025

Year

09

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065693