UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical utility and safety of a prototype 3D endoscope
Title of the study (Brief title)	Clinical utility and safety of a prototype 3D endoscope
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	safety of a prototype 3D endoscope
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	complications
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	endoscopy
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	nothing
Key exclusion criteria	nothing
Target sample size	60

Research contact person
Name of lead principal investigator	Kosuke Nomura
Organization	toranomon hospital
Division name	Department of Gastroenterology
Address	2-2-2 Toranomon, MInato-ku, Tokyo
TEL	03-3588-1111
Email	med20365nomura@yahoo.co.jp

Public contact
Name of contact person	Kosuke Nomura
Organization	toranomon hospital
Division name	Department of Gastroenterology
Address	2-2-2 Toranomon, MInato-ku, Tokyo
TEL	03-3588-1111
Homepage URL
Email	med20365nomura@yahoo.co.jp

Sponsor
Institute	toranomon hospital
Institute
Department

Funding Source
Organization	toranomon 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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 04 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 01 Month 04 Day
Anticipated trial start date	2016 Year 01 Month 04 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 11 Month 28 Day
Last modified on	2016 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028715