Zephyr Etude Post-Inscription (French Registry)

NCT04517916 | Completed DMC

• 1 other identifier: 630-0029-01
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Emphysema or COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treated Lobar Volume Reduction (TLVR)

  45 days

Other Outcomes (10)

• Absolute Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator

  Baseline, 6-months, 12-months, 24-months and 36-months

• Percent Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator

  Baseline, 6-months, 12-months, 24-months and 36-months

• Absolute Change in Residual Volume (RV)

  Baseline, 6-months, 12-months, 24-months and 36-months

Study Arms (1)

Zephyr Valve treatment

Patients undergoing the Zephyr Valve treatment for emphysema/COPD

Device: Zephyr Valve

Interventions

Zephyr Valve DEVICE

Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.

Also known as: Zephyr System, BLVR

Zephyr Valve treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).

Sponsors & Collaborators

• Pulmonx Corporation: lead

Study Sites (12)

Hôpital La Cavale Blanche

Brest, France

Location

Hôpital François Mitterrand

Dijon, France

Location

Hôpital Nord

Latronche, France

Location

Hôpital Calmette

Lille, France

Location

Hôpital Dupuytren

Limoges, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, France

Location

Hôpital Bichat

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Charles Nicolle

Rouen, France

Location

Hôpital Nord

Saint-Etienne, France

Location

Nouvel Hôpital Civil

Strasbourg, France

Location

Hôpital Larrey

Toulouse, France

Location

Related Publications (5)

• 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.

  PMID: 29787288 BACKGROUND

• 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.

  PMID: 28885054 BACKGROUND

• 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.

  PMID: 27580428 BACKGROUND

• 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.

  PMID: 26650153 BACKGROUND

• 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.

  PMID: 27974713 BACKGROUND

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Thomas Egenod, MD

  Hôpital Dupuytren (CHRU Limoges)

  PRINCIPAL INVESTIGATOR

• Dennis McHugh

  Pulmonx Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 19, 2020
• Study Start: January 4, 2021
• Primary Completion: June 22, 2022
• Study Completion: January 28, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

FR (12)