UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi
Acronym	Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi
Scientific Title	Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi
Scientific Title:Acronym	Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine and evaluate the safety and performance of applying the endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi in patients undergoing pulmonary resection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of bronchopleural fistula events within one month after pulmonary resection.
Key secondary outcomes	Incidence of postoperative complications

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	During surgical procedure
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients likely to undergo segmental resection (2 segments or less) or middle lobe resection using Powered ECHELON FLEX 7 2) Age 20 years or older 3) Performance status 0 or 1 (ECOG classification) 4) Sufficient function of major organs 5) Written informed consent for participation in the study
Key exclusion criteria	1) Patients likely to undergo 3 segmental resections all together, such as basal segmentectomy. Patients likely to undergo 3 segmental resections whose bronchus would be resected separately are not excluded. 2) Active bacterial and/or fungal infection 3) Continuous use of systemic steroids 4) Uncontrolled diabetes mellitus 5) Investigator judgement that participation in the study would be difficult due to mental disorders/symptoms 6) Previous thoracic radiotherapy/chemotherapy within the past year 7) Judgement by the surgeon in charge that the patient is not suitable for participation
Target sample size	65

Research contact person
Name of lead principal investigator	1st name Morihito Middle name Last name Okada
Organization	Hiroshima University Hospital
Division name	Surgical Oncology
Zip code	7340037
Address	1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037
TEL	082-257-5869
Email	morihito1217@gmail.com

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Miyata
Organization	Hiroshima University Hospital
Division name	Surgical Oncology
Zip code	734-0037
Address	1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037
TEL	082-257-5869
Homepage URL	http://home.hiroshima-u.ac.jp/genge/
Email	ymiyata@hiroshima-u.ac.jp

Sponsor
Institute	Surgical oncology, Hiroshima University Hospital / Department of Thoracic Surgery, Juntendo University Main Hospital
Institute
Department

Funding Source
Organization	Surgical oncology, Hiroshima University Hospital / Department of Thoracic Surgery, Juntendo University Main Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hiroshima University Certified Review Board
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
Tel	082-257-1551
Email	iryo-seisaku@office.hiroshima-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 12 Day
Date of IRB	2017 Year 08 Month 07 Day
Anticipated trial start date	2017 Year 10 Month 16 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 15 Day
Last modified on	2021 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033776