Clinical Trials Logo
  1. Home
  2. Pulmonary Emphysema
  3. NCT01580215

Long Term Follow up Investigation of Endobronchial Valves in Emphysema — LIVE  

Pulmonary Emphysema Clinical Trial

Official title:
Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Clinical Trial Summary

This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.

Clinical Trial Description

Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01580215
Study type Observational
Source Pulmonx, Inc.
Contact
Status Terminated
Phase N/A
Start date July 2012
Completion date September 2016
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT00995852 - Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study Phase 2/Phase 3
Completed NCT01860898 - A Phase I Study of iPS Cell Generation From Patients With COPD N/A
Completed NCT00123422 - Innovation in Pulmonary Rehabilitation N/A
Recruiting NCT02879331 - Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils N/A
Completed NCT01507415 - Do the SPPB and 4-metre Gait Speed Predict Hospital Readmission in Patients Hospitalised for Acute Exacerbation if COPD? N/A
Completed NCT01051258 - AeriSeal System for Lung Volume Reduction Phase 1/Phase 2
Completed NCT00680056 - Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients Phase 4
Completed NCT01872624 - Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema N/A
Completed NCT01110252 - Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease N/A
Completed NCT00517998 - Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study Phase 1
Terminated NCT00205920 - Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation Phase 2
Withdrawn NCT01849159 - Clinical Study of the Efficacy and Safety of the Application of Allogeneic Mesenchymal (Stromal) Cells of Bone Marrow, Cultured Under the Hypoxia in the Treatment of Patients With Severe Pulmonary Emphysema Phase 1/Phase 2
Completed NCT01869205 - The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients Phase 3
Terminated NCT01320566 - A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema Phase 2/Phase 3
Completed NCT00683722 - PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Active, not recruiting NCT04465461 - Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion N/A
Completed NCT04012359 - Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax
Recruiting NCT04918706 - Allogeneic MSC Treatment for Pulmonary Emphysema Phase 2
Terminated NCT01449292 - Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE) Phase 3
Completed NCT00347659 - US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study Phase 1