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Trial record 1 of 2 for:    "IMPACT" and "Zephyr"
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Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study (IMPACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc. ( Pulmonx International Sàrl )
ClinicalTrials.gov Identifier:
NCT02025205
First received: December 21, 2013
Last updated: July 27, 2016
Last verified: July 2016
  Purpose
The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.

Condition Intervention
COPD Patients With Homogeneous Emphysema Endoscopic Lung Volume Reduction With Endobronchial Valve Device: Endobronchial Valve

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema

Resource links provided by NLM:


Further study details as provided by Pulmonx, Inc. ( Pulmonx International Sàrl ):

Primary Outcome Measures:
  • Percentage change in Forced Expiratory Volume in 1 s (FEV1) [ Time Frame: At baseline and after 3 months ]

Secondary Outcome Measures:
  • Change in Quality of life (FEV1, SGRQ, CAT, EQ-5D) [ Time Frame: At baseline and after 3, 6 and 12 months ]
  • Change in Exercise Capacity (6-MWT) [ Time Frame: At baseline and after 3 and 6 months ]
  • Change in Dyspnea (mMRC) [ Time Frame: At baseline and after 3 and 6 months ]
  • Adverse Events and Serious Adverse Events [ Time Frame: At each visits ]

Enrollment: 93
Study Start Date: August 2014
Estimated Study Completion Date: January 2017
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ELVR with Endobronchial Valves
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
Device: Endobronchial Valve
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
No Intervention: Standard of Care
Patients will receive optimal drug therapy and medical management according to clinical practice.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Homogeneous emphysema
  • 15% < or = FEV1 < or = 45% predicted
  • TLC > 100% predicted
  • RV > or = 200% predicted
  • 6-MWT > or = 150 m
  • Non-smoker > 8 weeks prior to study entry
  • Absence of Collateral Ventilation in the target lobe

Exclusion Criteria:

  • Active pulmonary infection
  • More than 3 exacerbations with hospitalizations over the past 12 months
  • Pulmonary hypertension (sPAP > 45 mmHg)
  • MI or other relevant CV events in the past 6 months
  • Alpha-1 antitrypsin deficiency
  • Bronchiectasis
  • Prior LVR or LVRS procedure
  • > 20% difference in perfusion between right and left lung
  • Hypercapnia (paCO2 > 55 mmHg
  • Asthma
  • Use of more than 25 mg/day prednisolone or equivalent
  • Severe bullous emphysema
  • Systemic or malignant disease with high death probability within 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025205

Locations
Austria
Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
Vienna, Austria, 1140
Germany
Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Ruhrlandklinik, Westdeutsches Lungenzentrum
Essen, Germany, 45239
Lungenabteilung Thoraxzentrum Hamburg
Hamburg, Germany, 21075
Thoraxklinik am Universitäts klinikum Heidelberg
Heidelberg, Germany, 69126
Lungenklinik Hemer
Hemer, Germany, 58675
Klinikum Nürnberg Nord
Nürnberg, Germany, 90419
Netherlands
Department of pulmonary dieases, University Medical Center
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
Pulmonx International Sàrl
Investigators
Principal Investigator: Arschang Valipour, MD, PhD, FCCP Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology Otto-Wagner-Spital 1140 Wien / Austria
  More Information

Responsible Party: Pulmonx International Sàrl
ClinicalTrials.gov Identifier: NCT02025205     History of Changes
Other Study ID Numbers: 630-0014
Study First Received: December 21, 2013
Last Updated: July 27, 2016

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 27, 2017