To Improve Lung Function and Symptoms for Emphysema Patients Using Zephyr Valves
NCT ID: NCT02022683
Last Updated: 2019-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2014-01-28
2018-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endoscopic Lung Volume Reduction
Patients are implanted with Zephyr Valves
ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves
Standard of Care
Patients are given Standard Medical Care
No interventions assigned to this group
Interventions
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ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of heterogeneous emphysema with a heterogeneity index of ≥10 % between target and adjacent lobes.
3. Subjects of both genders of at least 40 years of age.
4. 15 % predicted ≤ FEV1≤ 45% predicted.
5. TLC \> 100% and RV ≥ 180% predicted.
6. 150 meters \< 6MWD \< 450 meters.
7. Non-smoker \>8 weeks prior to signing the Informed Consent.
8. CV negative target lobe.
Additional inclusion criterion French CIP\*:
\- If treated in France, Subject must be entitled to French social security
Exclusion Criteria
2. Evidence of active pulmonary infection.
3. History of 2 or more exacerbations requiring hospitalization over the past 12 months.
4. Known pulmonary hypertension that according to the physician will be unsuitable for EBV treatment.
5. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
6. Significant bronchiectasis seen at CT scan.
7. Greater than two tablespoons of sputum production per day.
8. Prior LVR or LVRS procedure. Criterion 8 French CIP wording\*: Prior lung transplant, median sternotomy, LVR or LVRS procedure (including lobectomy).
9. Pulmonary nodule requiring follow-up within any lobe.
10. Pregnant or nursing women. French CIP wording\*: Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
11. Hypercapnia (paCO2 \> 7.33 kPa).
12. Current diagnosis of asthma.
13. \> 25mg Prednisolon (or equivalent) use/days.
14. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate.
15. Evidence of pleural adhesions or earlier pulmonary surgery.
16. Severe Bullous Emphysema (\> 1/3 Hemithorax)
17. Any subject that according to the Declaration of Helsinki is unsuitable for enrollment.
* History of allergy to silicone and/or nitinol.
* If treated in France, Subject is a "personne vulnerable" as defined by French regulation.
* Simultaneous participation in another drug and/or medical device related clinical.
40 Years
ALL
No
Sponsors
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Pulmonx Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gunnar Hillerdal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital, Sweden
Locations
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Universiteit Gent
Ghent, , Belgium
AZ Delta
Menen, , Belgium
CHU
Grenoble, , France
CHU Hôpital Pasteur
Nice, , France
Groupe Hospitalier Pitié Salpétrière
Paris, , France
Hôpital Bichat Claude Bernard
Paris, , France
Charité Campus Virchow-Klinikum
Berlin, , Germany
Ruhrlandklinik Westdeutsches Lungenzentrum
Essen, , Germany
Thoraxklinik am Universitäts Klinikum Heidelberg
Heidelberg, , Germany
University Medical Center Groningen
Groningen, , Netherlands
Skane University Hospital
Lund, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Sherwood Forest Hospitals NHS
Sutton in Ashfield, Nottinghamshire, United Kingdom
West of Scotland Regional Heart & Lung Centre - Golden Jubilee National Hospital
Clydebank, West Dunbartonshire Scotland, United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
The Royal Brompton Hospital & Harefield NHS Foundation Trust
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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References
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Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.
Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hubner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.
Other Identifiers
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630-0015/A
Identifier Type: -
Identifier Source: org_study_id
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