UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical experimental study of induction of surgical robot for chest surgery using da Vinci S HD Surgical System, Intuitive Surgical Inc., USA
Title of the study (Brief title)	The clinical experimental study of robotic chest surgery
Region	Japan

Condition
Condition	Operative candidates of lung cancer and mediastinal tumor.
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To introduce of robotic chest surgery, we are planning to evaluate the safety and usefulness of da Vinci surgical system.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The safety and usefulness of da Vinci surgical system during the chest surgery. The postoperative physical status including pain, respiratory function and complications, 1 month after the surgery.
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	Maneuver
Interventions/Control_1	The chest surgery using the da Vinci surgical system.
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	The operative candidates of thoracic surgery
Key exclusion criteria	No indication of endoscopic surgery
Target sample size	50

Research contact person
Name of lead principal investigator	Isao Matsumoto
Organization	Kanazawa University
Division name	Department of Thoracic Cardiovascular and General Surgery
Address	13-1 Takara-machi, Kanazawa-city, Ishikawa prefecture, Japan
TEL	076-265-2354
Email	isa-mat@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Munehisa Takata
Organization	Kanazawa University
Division name	Department of Thoracic Cardiovascular and General Surgery
Address	13-1 Takara-machi, Kanazawa-city, Ishikawa prefecture, Japan
TEL	076-265-2354
Homepage URL
Email	takatamunehisa0223@yahoo.co.jp

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

Funding Source
Organization	Kanazawa University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 02 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 07 Month 26 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 29 Day
Last modified on	2017 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024125