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To Improve Lung Function and Symptoms for Emphysema Patients Using Zephyr EBV (TRANSFORM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT02022683
First received: December 17, 2013
Last updated: July 27, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
COPD
Heterogeneous Emphysema
Device: ELVR (Endoscopic Lung Volume Reduction) with Zephyr valve

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema

Resource links provided by NLM:


Further study details as provided by Pulmonx, Inc.:

Primary Outcome Measures:
  • Change in FEV1 [ Time Frame: Between baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in St George's Respiratory Questionnaire, 6-Min Walk Test, BODE index, mMRC score, [ Time Frame: Betwenn baseline and 3, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Changes in Target Lobar Volume Reduction (TLVR), Residual Volume, EQ-5D summary index, AEs and SAEs, paO2 [ Time Frame: Change in TLVR between baseline and 45 days ] [ Designated as safety issue: Yes ]

Enrollment: 97
Study Start Date: December 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic Lung Volume Reduction
Patients are implanted Zephyr EBV
Device: ELVR (Endoscopic Lung Volume Reduction) with Zephyr valve
Standard Medical Care
No Intervention: Standard of Care
Patients are given Standard of Care treatment

  Eligibility

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

Inclusion Criteria:

  • Heterogeneous emphysema
  • 15% pred < or = FEV1 < or = 45% pred
  • TLC > 100% and RV > or = 180%
  • 150 m < or = 6MWT < or = 450 m
  • No collateral ventilation

Exclusion Criteria:

  • Contraindication to bronchoscopy
  • Active pulmonary infection
  • History of 2 or more exacerbations with hospitalization over the past 12 months
  • Known pulmonary hypertension
  • Prior LVR or LVRS procedure
  • Pregnant or lactating woman
  • Hypercapnia
  • Current diagnosis of asthma
  • > 25 mg Prednisolon / day
  • CV in the target lobe or inconclusive Chartis assessment
  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: NCT02022683

Locations
Belgium
Universiteit Gent
Gent, Belgium, 9000
AZ Delta
Menen, Belgium, 8930
France
CHU
Grenoble, France, 38043
CHU Hôpital Pasteur
Nice, France, 06002
Groupe Hospitalier Pitié Salpétrière
Paris, France, 75013
Hôpital Bichat Claude Bernard
Paris, France, 75877
Germany
Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Ruhrlandklinik Westdeutsches Lungenzentrum
Essen, Germany, 45239
Thoraxklinik am Universitäts Klinikum Heidelberg
Heidelberg, Germany, 69126
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700
Sweden
Skane University Hospital
Lund, Sweden, 221 85
Uppsala University Hospital
Uppsala, Sweden, 751 85
United Kingdom
Sherwood Forest Hospitals NHS
Sutton in Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
West of Scotland Regional Heart & Lung Centre - Golden Jubilee National Hospital
West Dunbartonshire, West Dunbartonshire Scotland, United Kingdom, G81 4DY
University Hospital of Wales
Cardiff, United Kingdom, CF144XW
The Royal Brompton Hospital & Harefield NHS Foundation Trust
London, United Kingdom, SW3 6NP
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Pulmonx, Inc.
Investigators
Principal Investigator: Gunnar Hillerdal, MD, PhD Uppsala University Hospital Sweden
  More Information

Responsible Party: Pulmonx, Inc.
ClinicalTrials.gov Identifier: NCT02022683     History of Changes
Other Study ID Numbers: 630-0015/A 
Study First Received: December 17, 2013
Last Updated: July 27, 2016
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Pulmonx, Inc.:
Endoscopic lung volume reduction
Endobronchial valves

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 September 28, 2016