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