protocolSection identificationModule nctId: NCT06332885, orgStudyIdInfo id: 630-2001-01, briefTitle: Zephyr Valve Japan Post-Marketing Surveillance, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Pulmonx Corporation, class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months., conditionsModule conditions: Emphysema, conditions: COPD, conditions: Severe Emphysema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Zephyr Endobronchial Valve, outcomesModule primaryOutcomes measure: Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure., otherOutcomes measure: Forced Expiratory Volume in 1 second (FEV1), otherOutcomes measure: Residual Volume (RV), otherOutcomes measure: Treated lobe volume reduction (TLVR), otherOutcomes measure: Six-Minute Walk Distance (6MWD), otherOutcomes measure: Modified Medical Research Council Dyspnea (mMRC) Scale score, otherOutcomes measure: St. George's Respiratory Questionnaire (SGRQ) Total Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gifu Prefectural Medical Center, status: RECRUITING, city: Gifu, country: Japan, contacts name: Takahiro Masami, role: CONTACT, email: chiken-center.4289@gifu-hp.jp, contacts name: Fumihiro Asano, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.42291, lon: 136.76039, locations facility: Kanagawa Cardio Chest Center, status: RECRUITING, city: Kanagawa, country: Japan, contacts name: Takashi Niwa, MD, role: CONTACT, email: wanikko0714@gmail.com, contacts name: Takashi Niwa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.58333, lon: 139.91667, locations facility: Kanazawa University Hospital, status: RECRUITING, city: Kanazawa, country: Japan, contacts name: Satoshi Watanabe, MD, role: CONTACT, email: swatanabe@staff.kanazawa-u.ac.jp, contacts name: Satoshi Watanabe, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.6, lon: 136.61667, locations facility: St Marianna University Hospital, status: RECRUITING, city: Kawasaki, country: Japan, contacts name: Masamichi Mineshita, MD, role: CONTACT, email: m-mine@marianna-u.ac.jp, contacts name: Masamichi Mineshita, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.52056, lon: 139.71722, locations facility: Nagasaki University Hospital, status: RECRUITING, city: Nagasaki, country: Japan, contacts name: Keitaro Matsumoto, MD, role: CONTACT, email: kmatsumo@nagasaki-u.ac.jp, contacts name: Keitaro Matsumoto, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.75, lon: 129.88333, locations facility: Nagoya Medical Center, status: RECRUITING, city: Nagoya, country: Japan, contacts name: Masahide Oki, MD, role: CONTACT, email: masahideo@gmail.com, contacts name: Masahide Oki, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Okayama Medical Center, status: RECRUITING, city: Okayama, country: Japan, contacts name: Yanagihara, role: CONTACT, email: okmc-iec@nifty.com, contacts name: Ken Sato, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.65, lon: 133.93333, locations facility: Kinki Chuo Chest Medical Center, status: RECRUITING, city: Osaka, country: Japan, contacts name: Akihiro Tamiya, MD, role: CONTACT, email: tamiya.akihiro.tz@mail.hosp.go.jp, contacts name: Akihiro Tamiya, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Hokkaido University Hospital, status: RECRUITING, city: Sapporo, country: Japan, contacts name: Naofumi Shinagawa, MD, role: CONTACT, email: naop.shinagawa@nifty.ne.jp, contacts name: Naofumi Shinagawa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.06667, lon: 141.35, locations facility: Tohoku University Hospital, status: RECRUITING, city: Sendai, country: Japan, contacts name: Hirotsugu Notsuda, MD, role: CONTACT, email: hirotsugu.notsuda.c4@tohoku.ac.jp, contacts name: Hirotsugu Notsuda, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.26667, lon: 140.86667, locations facility: Shiga University Hospital, status: RECRUITING, city: Shiga, country: Japan, contacts name: Yasuki Uchida, MD, role: CONTACT, email: uchiy@belle.shiga-med.ac.jp, contacts name: Yasuki Uchida, MD, role: PRINCIPAL_INVESTIGATOR, locations facility: Tokyo National Hospital, status: RECRUITING, city: Tokyo, country: Japan, contacts name: Hiroyuki Tashimo, MD, role: CONTACT, contacts name: Hiroyuki Tashimo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Fujita Health University Hospital, status: RECRUITING, city: Toyoake, country: Japan, contacts name: Risako Koshiyama, role: CONTACT, email: gcpjim@fujita-hu.ac.jp, contacts name: Kazuyoshi Imaizumi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.038, lon: 136.99931, locations facility: Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology), status: NOT_YET_RECRUITING, city: Utsunomiya, country: Japan, contacts name: Yasuo Shimizu, MD, role: CONTACT, email: yasuo-s@dokkyomed.ac.jp, contacts name: Yasuo Shimizu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.56667, lon: 139.88333, locations facility: Dokkyo University Hospital, status: RECRUITING, city: Utsunomiya, country: Japan, contacts name: Masayuki Chida, MD, role: CONTACT, email: chidaths@dokkyomed.ac.jp, contacts name: Masayuki Chida, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.56667, lon: 139.88333, hasResults: False