UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study for assessing the effectiveness and safety of mediastinal tumor resection and extended thymectomy for myasthenia gravis by using the surgical robot system (da vinci S)
Title of the study (Brief title)	Mediastinal tumor resection and extended thymectomy by using the surgical robot system
Region	Japan

Condition
Condition	Mediastinal tumor, Myasthenia gravis
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the effectiveness and safety of mediastinal tumor resection and extended thymectomy for myasthenia gravis by using the surgical robot system (da vinci S)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Completeness of the resection of mediastinal tumors or thymus and surrounding adipose tissues
Key secondary outcomes	Operation time, Mortality and morbidity, Length of hospital stay, Degree of postoperative pain

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	Surgical treatment by using the surgical robot system (da vinci S)
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	Patients with a document agreement, who is recommended for tumor resection for the mediastinal mass or extended thymectomy for myasthenia gravis
Key exclusion criteria	Patients with invasive malignant mediastinal tumor, a history of thoracotomy, or cardio-pulmonary dysfunction, Patients without an informed consent
Target sample size	10

Research contact person
Name of lead principal investigator	Kohei Yokoi
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Thoracic Surgery
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2376
Email	k-yokoi@med.nagoya-u.ac.jp

Public contact
Name of contact person	Koji Kawaguchi
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Thoracic Surgery
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2376
Homepage URL
Email	gucci@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Thoracic Surgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Hospital
Organization
Division
Category of Funding Organization	Other
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	名古屋大学附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 03 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	2013 Year 01 Month 04 Day
Last modified on	2017 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011355