Clinical trial NCT04517916: Zephyr Etude Post-Inscription (French Registry)
Official title: Zephyr Etude Post-Inscription (French Registry)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Emphysema or COPD
Lead sponsor: Pulmonx Corporation
Sponsor class: INDUSTRY
First posted: 2020-08-19
Enrollment: 155
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 12 months
Secondary outcomes:
measure: Treated Lobar Volume Reduction (TLVR)
timeFrame: 45 days
Other outcomes:
measure: Absolute Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator
timeFrame: Baseline, 6-months, 12-months, 24-months and 36-months
measure: Percent Change in Forced Expiratory Volume in 1 second FEV1 Post-Bronchodilator
timeFrame: Baseline, 6-months, 12-months, 24-months and 36-months
measure: Absolute Change in Residual Volume (RV)
timeFrame: Baseline, 6-months, 12-months, 24-months and 36-months
measure: Percent Change in Residual Volume (RV)
timeFrame: Baseline, 6-months, 12-months, 24-months and 36-months
measure: Absolute Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: Baseline, 6-months and 12-months
measure: Percent Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: Baseline, 6-months and 12-months
measure: Absolute Change in Modified Medical Research Council (mMRC)
timeFrame: Baseline, 6-months and 12-months
measure: Percent Change in Modified Medical Research Council (mMRC)
timeFrame: Baseline, 6-months and 12-months
measure: Absolute Change in Six-Minute Walk Distance (6MWT)
timeFrame: Baseline, 6-months and 12-months.
measure: Percent Change in Six-Minute Walk Distance (6MWT)
timeFrame: Baseline, 6-months and 12-months.
Locations:
city: Brest
country: France
facility: Hôpital La Cavale Blanche
city: Dijon
country: France
facility: Hôpital François Mitterrand
city: LaTronche
country: France
facility: Hôpital Nord
city: Lille
country: France
facility: Hôpital Calmette
city: Limoges
country: France
facility: Hôpital Dupuytren
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Cochin
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: St. Etienne
country: France
facility: Hôpital Nord
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Toulouse
country: France
facility: Hôpital Larrey
Study officials:
affiliation: Hôpital Dupuytren (CHRU Limoges)
name: Thomas Egenod, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonx Corporation
name: Dennis McHugh
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.
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.