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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Pulmonx, Inc.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT02022683
First received: December 17, 2013
Last updated: November 19, 2014
Last verified: November 2014
  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 Primary Completion Date: August 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
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
  • Obstruction reversibility (pre vs post-BD FEV1) > 15%
  • 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         
CHU Hôpital Pasteur Recruiting
Nice, France, 06002
Contact: Charles Hugo Marquette, MD         
Hôpital Bichat Recruiting
Paris, France, 75877
Contact: Herve Mal, MD         
Ireland
University Galway Hospital Not yet recruiting
Galway, Ireland
Contact: David Breen, MD         
Sweden
Universitetssjukhuset i Linköping Recruiting
Linköping, Sweden, 581 85
Contact: Maria Ohman, MD         
Skane University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Lars Ek, MD         
Norrlands Universitetssjukhus Recruiting
Umea, Sweden, 901 85
Contact: Stefan Barath, 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: Samuel Kemp, MD         
Sponsors and Collaborators
Pulmonx, Inc.
Investigators
Principal Investigator: Gunnar Hillerdal, MD, PhD Uppsala University Hospital Sweden
  More Information

No publications provided

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: November 19, 2014
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
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014