UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026377 |
|---|---|
| Receipt number | 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 16:44:59 |
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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
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
hiro4884@med.kagawa-u.ac.jp
Sponsor or person
Institute
Ehime Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030313
