UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044640 |
|---|---|
| Receipt number | 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 | 2025/01/27 12:06:00 |
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Basic information
Public title
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-1200N 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 | Kenji |
| Middle name | |
| Last name | Ishido |
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
yfurue@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
yfurue@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato university School of Medicine
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 20 | Day |
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
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050540
