UMIN-CTR Clinical Trial

Basic information
Public title	An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with pulmonary arteries and veins in patients undergoing pulmonary resection
Acronym	An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with pulmonary arteries and veins in patients undergoing pulmonary resection
Scientific Title	An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with pulmonary arteries and veins in patients undergoing pulmonary resection
Scientific Title:Acronym	An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with pulmonary arteries and veins in patients undergoing pulmonary resection
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 LigaSure vessel sealing system to pulmonary arteries and veins in patients undergoing pulmonary resection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence rates of intra and post-operative bleeding within 28days
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 scheduled to undergo lung resection or segmentectomy with LigaSure 2)Above 20 years old 3)Performance Status 0-1 (ECOG classification) 4)Patients with preserved major organ function. 5)Consent from the patient for participating in the study is obtaine
Key exclusion criteria	1)Patients with active bacterial and/or fungal infections 2)Patients receiving continued systemic steroids 3)Patients with uncontrolled diabetes mellitus 4)Patients with psychiatric disorder or psychiatric symptoms that would preclude the participation in the study 5)Patients received thoracic radiation or chemotherapy within one year 6)Other patients who are considered by the investigator or sub-investigator as not suitable for participation in this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Morihito Okada / Kenji Suzuki
Organization	Hiroshima University Hospital / Juntendo University School of Medicine
Division name	Oncological surgery / General Thoracic Surgery
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037 / 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
TEL	082-257-5555
Email	ymiyata@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshihiro Miyata / Kazuya Takamochi
Organization	Hiroshima University Hospital / Juntendo University School of Medicine
Division name	Oncological surgery / General Thoracic Surgery
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037 / 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-843
TEL	082-257-5555
Homepage URL
Email	ymiyata@hiroshima-u.ac.jp

Sponsor
Institute	Oncological surgery, Hiroshima University Hospital / Department of Thoracic Surgery, Juntendo University Main Hospital
Institute
Department

Funding Source
Organization	No
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
Address
Tel
Email

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	2015 Year 07 Month 30 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	2015 Year 04 Month 02 Day
Date of IRB	2015 Year 06 Month 07 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A prospective, single-arm, multicenter, observational study

Management information
Registered date	2015 Year 07 Month 30 Day
Last modified on	2019 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021409