UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Neoveil covering ESD by novel Device Delivery Station System (DDSS) compared to Conventional Neoveil-ESD(CN-ESD) in Neoveil placement time: a randomized prospective study
Title of the study (Brief title)	Novel Device Delivery Station System (DDSS)
Region	Japan

Condition
Condition	Early differentiated gastric cancer over 20 mm in diameter
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of Neoveil covering ESD by novel Device Delivery Station System (DDSS) compared to Conventional Neoveil-ESD(CN-ESD) in Neoveil placement time and prevention of post ESD bleeding.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Difference of covering time between CN-ESD group and DDSS-ESD group
Key secondary outcomes	1.Post ESD bleeding 2.Post ESD perforation 3.Post ESD Deformity and stasis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Novel Device Delivery Station System (DDSS)
Interventions/Control_2	Conventinal ESD
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Early differentiated gastric cancer over 20 mm in diameter diagnosed with narrow band imaging magnified endoscopy and biopsy.
Key exclusion criteria	Exclusion criteria of definite advanced gastric cancer.
Target sample size	60

Research contact person
Name of lead principal investigator	Hirohito Mori
Organization	Ehime Rosai Hospital
Division name	Department of Gastroenterology
Address	13-27, minami komatubara, niihama, Ehime, Japan
TEL	0897-33-6191
Email	hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person	Hirohito Mori
Organization	Ehime Rosai Hospital
Division name	Department of Gastroenterology
Address	13-27, minami komatubara, niihama, Ehime, Japan
TEL	0897-33-6191
Homepage URL
Email	hiro4884@med.kagawa-u.ac.jp

Sponsor
Institute	Ehime Rosai Hospital
Institute
Department

Funding Source
Organization	Ehime Rosai 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	YES
Study ID_1	85
Org. issuing International ID_1	Ehime Rosai Hospital
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 03 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 03 Day
Anticipated trial start date	2017 Year 03 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 10 Month 01 Day
Date analysis concluded

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

Management information
Registered date	2017 Year 03 Month 03 Day
Last modified on	2018 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030313