Endobronchial Valve in Patients With Heterogeneous Emphysema

NCT02823223 | Unknown DMC

• 1 other identifier: S2016-026-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema patients in a controlled trial design setting.

Conditions

Chronic Obstructive Pulmonary Disease; Emphysema

Keywords

Endobronchial Valve

Outcome Measures

Primary Outcomes (1)

• Percentage change in Forced Expiratory Volume in 1 s (FEV1)

  At baseline and after 3 months

Secondary Outcomes (10)

• Percentage change in Forced Expiratory Volume in 1 s (FEV1)

  At baseline and after 6 months

• Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change

  At baseline and after 3, 6 months

• Change in Residual Volume (RV)

  At baseline and after 3, 6 months

• Change in Total Lung Capacity (TLC)

  At baseline and after 3, 6 months

• Change in FEV1/FVC ratio

  At baseline and after 3, 6 months

Study Arms (2)

ELVR with Endobronchial Valves

EXPERIMENTAL

Patients will have ELVR (Endoscopic Lung Volume Reduction) with Endobronchial Valves (Zephyr valve) inserted into the target lobe of the lung with the aim of complete lobar exclusion.

Device: Zephyr endobronchial valve placement

Standard of Care

NO INTERVENTION

Patients will receive optimal drug therapy and medical management according to clinical practice

Interventions

Zephyr endobronchial valve placement DEVICE

Patients will have ELVR (Endoscopic Lung Volume Reduction) with Zephyr valve inserted into the target lobe of the lung with the aim of complete lobar exclusion.

ELVR with Endobronchial Valves

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent form signed
• Heterogeneous emphysema on Chest CT Scanner
• Intact interlobar fissures adjacent to the target lobe on Chest CT or collateral ventilation negative in the target lobe by Chartis assessment
• Post bronchodilator Forced expiratory volume in 1 second (FEV1) \< 50% predicted
• Total Lung Capacity \> 100% predicted
• Residual Volume \> 150% predicted
• PaO2 \> 45mmHg
• Post rehabilitation 6 minute walk test \> 140m
• No COPD exacerbation for at least 6 weeks
• Stopped cigarette smoking for more than 3 months

You may not qualify if:

• Contraindication to bronchoscopy
• Tuberculosis, pleural effusion, or clinically significant bronchiectasis
• Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
• Active pulmonary infection
• Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
• Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
• Pregnant or lactating woman

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liang_an Chen, MD, phD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

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: MD,PHD

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: July 6, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)