Zephyr Etude Post-Inscription (French Registry)

The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.

Study Overview

• Status: Active, not recruiting
• Conditions: Emphysema or COPD
• Intervention / Treatment: Device: Zephyr Valve

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: Observational
• Enrollment (Actual): 155

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

• France
  • Brest, France
    • Hopital La Cavale Blanche
  • Dijon, France
    • Hôpital François Mitterrand
  • LaTronche, France
    • Hopital Nord
  • Lille, France
    • Hopital Calmette
  • Limoges, France
    • Hopital Dupuytren
  • Montpellier, France
    • Hopital Arnaud de Villeneuve
  • Paris, France
    • Hopital Bichat
  • Paris, France
    • Hôpital Cochin
  • Rouen, France
    • Hopital Charles Nicolle
  • St. Etienne, France
    • Hopital Nord
  • Strasbourg, France
    • Nouvel Hopital Civil
  • Toulouse, France
    • Hopital Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is an all-comers Registry. Physicians at participating study centers will invite consecutive patients who are prescribed Zephyr Valve treatment to participate in the Registry and allow data collection.

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Zephyr Valve treatment; Patients undergoing the Zephyr Valve treatment for emphysema/COPD	Device: Zephyr Valve; Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.; Other Names: BLVR; Zephyr System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in 1 second (FEV1)	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)	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	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
Percent Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator	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)	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)	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	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
Percent Change in St. George's Respiratory Questionnaire (SGRQ) Total Score	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)	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)	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
Absolute Change in Six-Minute Walk Distance (6MWT)	Absolute change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months.	Baseline, 6-months and 12-months.
Percent Change in Six-Minute Walk Distance (6MWT)	Percent change in Six-Minute Walk Distance (from 6MWT) from Baseline to 6-months and 12-months.	Baseline, 6-months and 12-months.

Collaborators and Investigators

• Sponsor: Pulmonx Corporation
• 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): January 4, 2021
• Primary Completion (Actual): June 22, 2022
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Emphysema
• Other Study ID Numbers: 630-0029-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes