- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04517916
Zephyr Etude Post-Inscription (French Registry)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a multi-center, single-arm, prospective Registry to be conducted at a minimum of 12 study centers. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Dennis McHugh
- Phone Number: 925 785-5237
- Email: dmchugh@pulmonx.com
Study Contact Backup
- Name: Nina Mohmood
- Phone Number: 650-216-0106
- Email: nmohmood@pulmonx.com
Study Locations
-
-
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Brest, France
- Hopital La Cavale Blanche
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Dijon, France
- Hôpital François Mitterrand
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LaTronche, France
- Hopital Nord
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Lille, France
- Hopital Calmette
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Limoges, France
- Hopital Dupuytren
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Montpellier, France
- Hopital Arnaud de Villeneuve
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Paris, France
- Hopital Bichat
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Paris, France
- Hôpital Cochin
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Rouen, France
- Hopital Charles Nicolle
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St. Etienne, France
- Hopital Nord
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Strasbourg, France
- Nouvel Hopital Civil
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Toulouse, France
- Hopital Larrey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with emphysema (COPD Grade III and Grade IV) considered appropriate for the bronchoscopic lung volume reduction procedure by the physician.
- Subjects who signed an Informed Consent Form to allow data collection.
Exclusion Criteria:
- Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Zephyr Valve treatment
Patients undergoing the Zephyr Valve treatment for emphysema/COPD
|
Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 12 months
|
The percent of patients achieving an improvement in the post-bronchodilator FEV1 of ≥12% at 12-months.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treated Lobar Volume Reduction (TLVR)
Time Frame: 45 days
|
Treated Lobar Volume Reduction (TLVR) assessed by High Resolution Computed Tomography (HRCT) at 45-days.
|
45 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator
Time Frame: Baseline, 6-months, 12-months, 24-months and 36-months
|
Absolute Change in FEV1 from Baseline to 6-months, 12-months, 24-months and 36-months.
|
Baseline, 6-months, 12-months, 24-months and 36-months
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Percent Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator
Time Frame: Baseline, 6-months, 12-months, 24-months and 36-months
|
Percent change in FEV1 from Baseline to 6-months, 12-months, 24-months and 36-months.
|
Baseline, 6-months, 12-months, 24-months and 36-months
|
Absolute Change in Residual Volume (RV)
Time Frame: Baseline, 6-months, 12-months, 24-months and 36-months
|
Absolute Change in Residual Volume (RV) from Baseline to 6-months, 12-months, 24-months and 36-months.
|
Baseline, 6-months, 12-months, 24-months and 36-months
|
Percent Change in Residual Volume (RV)
Time Frame: Baseline, 6-months, 12-months, 24-months and 36-months
|
Percent change in Residual Volume (RV) from Baseline to 6-months, 12-months, 24-months and 36-months.
|
Baseline, 6-months, 12-months, 24-months and 36-months
|
Absolute Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: Baseline, 6-months and 12-months
|
Absolute change in St. George's Respiratory Questionnaire (SGRQ) from Baseline to 6-months and 12-months. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. |
Baseline, 6-months and 12-months
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Percent Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: Baseline, 6-months and 12-months
|
Percent change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to 6-months and 12-months. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. |
Baseline, 6-months and 12-months
|
Absolute Change in Modified Medical Research Council (mMRC)
Time Frame: Baseline, 6-months and 12-months
|
Absolute Change in the Modified Medical Research Council (mMRC) Dyspnea Scale from Baseline to 6-months and 12-months. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations. |
Baseline, 6-months and 12-months
|
Percent Change in Modified Medical Research Council (mMRC)
Time Frame: Baseline, 6-months and 12-months
|
Percent change in the Modified Medical Research Council (mMRC) Dyspnea Scale from Baseline to 6-months and 12-months. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations. |
Baseline, 6-months and 12-months
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Absolute Change in Six-Minute Walk Distance (6MWT)
Time Frame: Baseline, 6-months and 12-months.
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Absolute change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months.
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Baseline, 6-months and 12-months.
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Percent Change in Six-Minute Walk Distance (6MWT)
Time Frame: Baseline, 6-months and 12-months.
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Percent change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months.
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Baseline, 6-months and 12-months.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Egenod, MD, Hôpital Dupuytren (CHRU Limoges)
- Study Director: Dennis McHugh, Pulmonx Corporation
Publications and helpful links
General Publications
- 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.
- 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, 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 630-0029-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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