UMIN-CTR Clinical Trial

Basic information
Public title	A phase ll study of robot assisted lobectomy for lung cancer
Acronym	A phase ll study of robot assisted lobectomy for lung cancer
Scientific Title	A phase ll study of robot assisted lobectomy for lung cancer
Scientific Title:Acronym	A phase ll study of robot assisted lobectomy for lung cancer
Region	Japan

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

Objectives
Narrative objectives1	Safety of robotic assisted thoracoscopic lobectomy using da Vinci surgical system for primary lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Safety
Key secondary outcomes

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	surgery
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. patients with lung cancer 2. The patients who have not undergone open thoracotomy 3. patinets maintaining the function the main organ 4. A case that document agreement by the examination participation
Key exclusion criteria	Patients with severe or complicated medical conditions, not allowing participation into this protocol
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhisa Ohde
Organization	Shizuoka Cancer Center Hospital
Division name	Division of Thoracic Surgery
Zip code
Address	1007, Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL	055-989-5222
Email	y.ode@scchr.jp

Public contact
Name of contact person	1st name Middle name Last name Hideaki Kojima
Organization	Shizuoka Cancer Center Hospital
Division name	Division of Thoracic Surgery
Zip code
Address	1007, Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL	055-989-5222
Homepage URL
Email	h.kojima@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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 01 Month 20 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	Preinitiation
Date of protocol fixation	2015 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date	2015 Year 01 Month 20 Day
Last follow-up date	2020 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 02 Month 12 Day

Other
Other related information

Management information
Registered date	2015 Year 01 Month 20 Day
Last modified on	2020 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018799