UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical application of robot-assisted thoracoscopic surgery using da Vinci S HD surgical system for mediastinal diseases
Title of the study (Brief title)	Clinical application of robot-assisted thoracoscopic surgery for mediastinal diseases
Region	Japan

Condition
Condition	mediastinal diseases
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy, usability and safety of robot-assisted thoracoscopic surgery using da Vinci S HD system for mediastinal diseases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Length of hospital stay
Key secondary outcomes	Intra- and post-operative adverse events

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	Endoscopic surgery using da Vinci S HD 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Patients maintaining the functions of the main organs 2 A case that an operation under the general anesthesia is possible 3 No past history of the thoracic surgery 4 A case that a document agreement by the examination participation
Key exclusion criteria	1 Pregnant or potentially women, nursing women 2 Past history of the thoracic surgery 3 Patients with mediastinal tumor that invade of heart or great vessels directly 4 Patients with psychiatric diseases 5 A case that a document disagreement by the examination participation 6 Patients with severe or complicated medical conditions, not allowing partcipation into this protocol
Target sample size	20

Research contact person
Name of lead principal investigator	Takamasa Onuki
Organization	Tokyo Women's Medical University
Division name	Department of Surgery I
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	0333538111
Email	tonuki@twmu.ac.jp

Public contact
Name of contact person	Masato Kanzaki
Organization	Tokyo Women's Medical University
Division name	Department of Surgery I
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	0333538111
Homepage URL
Email	kanzaki@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University, Department of Surgery I
Institute
Department

Funding Source
Organization	None
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	2015 Year 08 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 04 Day
Anticipated trial start date	2015 Year 09 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	2015 Year 08 Month 07 Day
Last modified on	2019 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021515