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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044640
Receipt No. R000050540
Scientific Title Visibility evaluation study of upper gastrointestinal endoscopy for esophageal and gastric cancer using the GIF-1200N ultra-fine diameter general-purpose upper gastrointestinal videoscope
Date of disclosure of the study information 2021/06/30
Last modified on 2021/06/24

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Basic information
Public title A single-center prospective observational study to investigate the visibility of endoscopic findings of esophageal and gastric cancers using the GIF-1200N ultra-fine diameter general-purpose upper gastrointestinal videoscope
Acronym Visibility study of upper gastrointestinal endoscopy for esophageal and gastric cancer
Scientific Title Visibility evaluation study of upper gastrointestinal endoscopy for esophageal and gastric cancer using the GIF-1200N ultra-fine diameter general-purpose upper gastrointestinal videoscope
Scientific Title:Acronym Visibility study of upper gastrointestinal endoscopy for esophageal and gastric cancer
Region
Japan

Condition
Condition Esophageal cancer, Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the visibility of endoscopic findings of esophageal and gastric cancer using images obtained with the GIF-1200N, GIF-EZ1500, and GIF-XZ1200 general-purpose videoscopes for the upper gastrointestinal tract.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Evaluation of the equivalence between the visibility of endoscopic findings of GIF-1200 and those of GIF-EZ1500 and GIF-XZ1200
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 At the time of upper endoscopy, endoscopic observation of the lesion will be performed using GIF-XZ1200 or GIF-EZ1500. 5 minutes later, endoscopic observation of the lesion will be performed using GIF-1200N. The duration of intervention is 1 day and the number of interventions is 1 time.
Interventions/Control_2
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) Patients who are at least 20 years old at the time of participation in this study.
(2) Patients who are scheduled to undergo endoscopic resection.
(3) Patients who have given written consent to use the GIF-1200N and the GIF-EZ1500 or GIF-XZ1200 for observation immediately before endoscopic resection.
Key exclusion criteria Patients whose participation in this study is judged inappropriate by the physician in charge.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Chikatoshi
Middle name
Last name Katada
Organization Kitasato university School of Medicine
Division name Gatroenterology
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL 042-778-8111
Email ckatada@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Yasuaki
Middle name
Last name Furue
Organization Kitasato university School of Medicine
Division name Gatroenterology
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL 042-778-8111
Homepage URL
Email yfurue@kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Kitasato university School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology, Kitasato university School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Review Office, Kitasato University Hospital
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel 042-778-8273
Email rinrib@med.kitasato-u.ac.jp

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 北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 30 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
2021 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2021 Year 08 Month 01 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 24 Day
Last modified on
2021 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050540

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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