UMIN-CTR Clinical Trial

Basic information
Public title	Verification of usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic therapy
Acronym	Verification of usefulness and safety of 3-dimensional flexible endoscopy in endoscopic therapy
Scientific Title	Verification of usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic therapy
Scientific Title:Acronym	Verification of usefulness and safety of 3-dimensional flexible endoscopy in endoscopic therapy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the usefulness and safety of a newly developed 3-dimensional flexible endoscopy in endoscopic submucosal dissection for early gastric cancers and gastric adenomas.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. diagnosed degree of perception of lesion 2. correct diagnosis rate of lesion range
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Endoscopic diagnosis and endoscopic therapy with 2D vision or 3D vision
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients who have been diagnosed with early gastric cancers or gastric adenomas 2.Patients who understood study, and provided written consent based on their own will
Key exclusion criteria	1.Patients in pregnancy or lactation 2.Patients who ever participated other clinical trials in latest 3 months 3.Patients decided to be contraindicated by the person in charge
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazutoshi Higuchi
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Zip code
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	k-higuchi@nms.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazutoshi Higuchi
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Zip code
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	k-higuchi@nms.ac.jp

Sponsor
Institute	Nippon Medical School Hospital
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)

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	2018 Year 09 Month 02 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	Completed
Date of protocol fixation	2018 Year 06 Month 22 Day
Date of IRB	2018 Year 06 Month 08 Day
Anticipated trial start date	2018 Year 09 Month 03 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 02 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038760

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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