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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042429
Receipt No. R000047938
Scientific Title Usability of Texture and Color Enhancement Imaging (TXI), image enhanced endoscopy system, for diagnosing gastric cancer: a prospective trial
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/12

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Basic information
Public title Usability of TXI for diagnosing gastric cancer
Acronym Usability of TXI for diagnosing gastric cancer
Scientific Title Usability of Texture and Color Enhancement Imaging (TXI), image enhanced endoscopy system, for diagnosing gastric cancer: a prospective trial
Scientific Title:Acronym Usability of TXI for diagnosing gastric cancer
Region
Japan

Condition
Condition superficial gastric neoplasms
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Usability of TXI for diagnosing gastric neoplasms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of visibility for gastric neoplasms (white light imaging vs. TXI)
Key secondary outcomes 1. Visibility (GIF-H290Z vs. GIF-EZ1500)

2. Correlation of characteristics of detectable or undetectable lesion in WLI or TXI

3. Detection rate in WLI or TXI

4. Inter-observer agreement

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Endoscopy (GIF-H290Z)
Interventions/Control_2 Endoscopy (GIF-EZ1500)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patients with present history of gastric neoplasms

2. Patients who agree with the informed consent.
Key exclusion criteria 1.A Patient aged < 20
2. A patient who is pregnant
3. A lesion more than 8 cm

4.The patients who are evaluated inappropriate for the resear
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Dobashi
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code 105-8463
Address 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL 03-0344-1111
Email ad99061@jikei.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Dobashi
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code 105-0861
Address 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL 03-0433-1111
Homepage URL
Email ad99061@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization Research fund of The Jikei University School of Medicine, Department of Endoscopy
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 The Jikei University School of Medicine
Address 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
Tel 03-3433-1111
Email rinri@jikei.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 32-156(10237)
Org. issuing International ID_1 IRB at The Jikei University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 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
2020 Year 09 Month 14 Day
Date of IRB
2020 Year 09 Month 14 Day
Anticipated trial start date
2020 Year 10 Month 15 Day
Last follow-up date
2021 Year 09 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 12 Day
Last modified on
2020 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047938

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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