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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ACTIVE_NOT_RECRUITING
155 participants
OBSERVATIONAL
2021-01-04
2025-09-30
Brief Summary
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Detailed Description
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Patients prescribed the Zephyr Valve treatment will be consented and will be enrolled only after determination of little to no collateral ventilation between target and ipsilateral lobes. Safety and effectiveness of the Zephyr Valve treatment will be evaluated post-treatment based on data collected out to 3-years post-treatment.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Zephyr Valve treatment
Patients undergoing the Zephyr Valve treatment for emphysema/COPD
Zephyr Valve
Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.
Interventions
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Zephyr Valve
Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who signed an Informed Consent Form to allow data collection.
Exclusion Criteria
ALL
No
Sponsors
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Pulmonx Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Egenod, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Dupuytren (CHRU Limoges)
Dennis McHugh
Role: STUDY_DIRECTOR
Pulmonx Corporation
Locations
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Hôpital La Cavale Blanche
Brest, , France
Hôpital François Mitterrand
Dijon, , France
Hôpital Nord
Latronche, , France
Hôpital Calmette
Lille, , France
Hôpital Dupuytren
Limoges, , France
Hôpital Arnaud de Villeneuve
Montpellier, , France
Hôpital Bichat
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Charles Nicolle
Rouen, , France
Hôpital Nord
Saint-Etienne, , France
Nouvel Hôpital Civil
Strasbourg, , France
Hôpital Larrey
Toulouse, , France
Countries
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References
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Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164. doi: 10.1164/rccm.201803-0590OC.
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.
Valipour A, Slebos DJ, Herth F, Darwiche K, Wagner M, Ficker JH, Petermann C, Hubner RH, Stanzel F, Eberhardt R; IMPACT Study Team. Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study. Am J Respir Crit Care Med. 2016 Nov 1;194(9):1073-1082. doi: 10.1164/rccm.201607-1383OC.
Klooster K, ten Hacken NH, Hartman JE, Kerstjens HA, van Rikxoort EM, Slebos DJ. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015 Dec 10;373(24):2325-35. doi: 10.1056/NEJMoa1507807.
Klooster K, Hartman JE, Ten Hacken NH, Slebos DJ. One-Year Follow-Up after Endobronchial Valve Treatment in Patients with Emphysema without Collateral Ventilation Treated in the STELVIO Trial. Respiration. 2017;93(2):112-121. doi: 10.1159/000453529. Epub 2016 Dec 15.
Other Identifiers
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630-0029-01
Identifier Type: -
Identifier Source: org_study_id
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