NCT07097896

Brief Summary

The purpose of this research is to compare the efficacy and safety between endobronchial silicone valve and endobronchial valve in bronchoscopic lung volume reduction in patients with severe emphysema.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jul 2025Jul 2027

Study Start

First participant enrolled

July 1, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

July 30, 2025

Last Update Submit

July 30, 2025

Conditions

Emphysema

Keywords

Endobronchial Lung Volume ReductionEmphysemaChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in 1-second (FEV1)

    Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).

    1-year

Secondary Outcomes (3)

  • FEV1 Post-bronchodilator Absolute Change

    1 year

  • St. George's Respiratory Questionnaire (SGRQ)

    1 year

  • 6-minute Walk Distance

    1 year

Study Arms (2)

ESV and Optimal Medical Management

EXPERIMENTAL

This study arm will undergo ESV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

Device: ESV

EBV and Optimal Medical Management

OTHER

This study arm will undergo EBV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

Device: EBV

Interventions

ESVDEVICE

This study arm will undergo ESV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

ESV and Optimal Medical Management
EBVDEVICE

This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

EBV and Optimal Medical Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and radiological evidence of emphysema
  • Nonsmoking for 4 months prior to screening interview
  • BMI less than 35 kg/m2
  • Stable on current medication regimen
  • Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
  • Residual Volume less than 175% predicted (determined by body plethysmography)
  • Little or no collateral ventilation (CV-) as determined using the Chartis System

You may not qualify if:

  • Had two or more hospitalizations over the last year for a COPD exacerbation
  • Had two or more hospitalizations over the last year for pneumonia
  • Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
  • Had a heart attack or congestive heart failure within the last 6 months
  • Have heart arrhythmia
  • Is alpha-1 antitrypsin deficient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

EmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Central Study Contacts

Mingming Deng, PhD., MD.

CONTACT

+86 18801336854isdeng1017@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 1, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)