UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042429 |
|---|---|
| Receipt number | 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 | 2022/09/29 18:39:42 |
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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 or GIF-XZ1200)
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
Non-randomized
Randomization unit
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 or GIF-XZ1200)
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
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
ad99061@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 29 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 29 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 12 | Day |
Last modified on
| 2022 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047938
