Zephyr Etude Post-Inscription (French Registry)

Emphysema or COPD Clinical Trial

Official title:

Zephyr Etude Post-Inscription (French Registry)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04517916
• Other study ID #: 630-0029-01
• Status: Active, not recruiting
• Start date: January 4, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2023
• Source: Pulmonx Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: September 30, 2025
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Emphysema
• Emphysema or COPD

Intervention

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

Locations

Country	Name	City	State
France	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	St. Etienne
France	Nouvel Hôpital Civil	Strasbourg
France	Hôpital Larrey	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonx Corporation

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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.
Other	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.
Primary	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	Treated Lobar Volume Reduction (TLVR)	Treated Lobar Volume Reduction (TLVR) assessed by High Resolution Computed Tomography (HRCT) at 45-days.	45 days