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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026377
Receipt No. R000030313
Scientific Title 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
Date of disclosure of the study information 2017/03/03
Last modified on 2018/10/11

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Basic information
Public title 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
Acronym Novel Device Delivery Station System (DDSS)
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirohito Mori
Organization Ehime Rosai Hospital
Division name Department of Gastroenterology
Zip code
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
1st name
Middle name
Last name Hirohito Mori
Organization Ehime Rosai Hospital
Division name Department of Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 03 Month 03 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000030313

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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