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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Pulmonx, Inc.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT02022683
First received: December 17, 2013
Last updated: March 22, 2016
Last verified: October 2015
  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 ]

Estimated Enrollment: 78
Study Start Date: December 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: May 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

Contacts
Contact: Elisabeth Liljensten, DDS, PhD 0046-723 61 1968 elisabeth.liljensten@devicia.se

Locations
Belgium
Universiteit Gent Recruiting
Gent, Belgium, 9000
Contact: Eric Derom, MD         
Contact: Thomas Malfait, MD         
AZ Delta Recruiting
Menen, Belgium, 8930
Contact: Kris Carron, MD         
France
CHU Recruiting
Grenoble, France, 38043
Contact: Christophe Pison, MD, Pr         
CHU Hôpital Pasteur Recruiting
Nice, France, 06002
Contact: Charles Hugo Marquette, MD, Pr         
Groupe Hospitalier Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: Valéry Trosini-Desert, MD         
Hôpital Bichat Claude Bernard Recruiting
Paris, France, 75877
Contact: Hervé Mal, MD         
Germany
Charité Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
Contact: Ralf-Harto Hübner, MD         
Ruhrlandklinik Westdeutsches Lungenzentrum Recruiting
Essen, Germany, 45239
Contact: Kaid Darwiche, MD         
Thoraxklinik am Universitäts Klinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Felix Herth, MD         
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700
Contact: Dirk-Jan Slebos, MD, PhD         
Sweden
Skane University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Lars Ek, MD         
Uppsala University Hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Gunnar Hillerdal, MD         
United Kingdom
Sherwood Forest Hospitals NHS Recruiting
Sutton in Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
Contact: Nicola Downer, MD         
West of Scotland Regional Heart & Lung Centre - Golden Jubilee National Hospital Recruiting
West Dunbartonshire, West Dunbartonshire Scotland, United Kingdom, G81 4DY
Contact: Alan Kirk, FRCS         
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF144XW
Contact: Margaret Kornaszewska, MD         
The Royal Brompton Hospital & Harefield NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6NP
Contact: Samuel Kemp, MD         
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S5 7AU
Contact: Jagan Rao, MD         
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: March 22, 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 July 25, 2016