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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026111
Receipt No. R000029865
Scientific Title Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial.
Date of disclosure of the study information 2017/02/13
Last modified on 2017/02/13

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Basic information
Public title Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial.
Acronym Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial.
Scientific Title Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial.
Scientific Title:Acronym Detection of the neoplastic stomach lesions using ultrathin endoscope with the novel image enhanced endoscopy (IEE): A randomized controlled clinical trial.
Region
Japan

Condition
Condition The patients who underwent upper gastrointestinal endoscopy.
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the novel image enhanced endoscopy (IEE) observation compared with the conventional white light (WLI) observation in detecting neoplastic stomach lesions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Superiority in detectability of neoplastic stomach lesions using a novel IEE as compared to WLI.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Image enhanced endoscopy (IEE)
Interventions/Control_2 White ligth (Xenon)
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 - A person who undergo UGD endoscopy for the screening of the multi-focal cancer (synchronous / metachronous)
- age ranged from 20 years to 80 years
Key exclusion criteria - A person who is untolerable for a biopsy
- A person who is unsuitable to undergo the procedure
- A person who did not agree to participate.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Ito
Organization Kanazawa Medical University
Division name Gastroenterological Endoscopy
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Email itotohru@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Ito
Organization Kanazawa Medical University
Division name Gastroenterological Endoscopy
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Homepage URL
Email itotohru@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Kanazawa Medical University
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
2017 Year 02 Month 13 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 13 Day
Last modified on
2017 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029865

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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