UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054752 |
|---|---|
| Receipt number | R000062429 |
| Scientific Title | Study on Differential Diagnostic Ability of Colonoscopy Diagnostic Software EndoBRAIN-X in JNET type1 Lesions |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/06/25 09:21:09 |
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Basic information
Public title
Study on Differential Diagnostic Ability of Colonoscopy Diagnostic Software EndoBRAIN-X in JNET type1 Lesions
Acronym
EndoBRAIN challenge study X1
Scientific Title
Study on Differential Diagnostic Ability of Colonoscopy Diagnostic Software EndoBRAIN-X in JNET type1 Lesions
Scientific Title:Acronym
EndoBRAIN challenge study X1
Region
| Japan |
Condition
Condition
Colorectal serrated lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the differential diagnostic ability of EndoBRAIN-X colonoscopy imaging support software in JNET Type 1 lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differential diagnostic performance of EndoBRAIN-X in JNET Type 1 lesions >6 mm (accuracy, sensitivity, specificity, positive predictive value, negative predictive value)
Key secondary outcomes
Stability of EndoBRAIN-X determination results and rate of agreement with expert's diagnosis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients 20 years of age or older undergoing colonoscopy with JNET Type 1 lesions of 6 mm or greater.
Key exclusion criteria
1.Patients with a history of surgery involving colorectal resection other than appendicectomy
2. Patients with concomitant inflammatory bowel disease; ulcerative colitis, Crohn's disease, etc
3. Patients with six or more JNET Type 1 lesions measuring at least 6 mm or complicated with polyposis coli or hereditary non-polyposis colorectal cancer
4. Patients taking antiplatelet or anticoagulant drugs
5. Pregnant, lactating, or possibly pregnant at the time of examination
6. Patients with other more serious concurrent illnesses, etc., for which the physician in charge determines that the patient is not suitable for the procedure.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daizen |
| Middle name | |
| Last name | Hirata |
Organization
Sano hospital
Division name
Gastrointestinal Center, & Institute of Minimally-Invasive Endoscopic Care
Zip code
6550031
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, 655-0031, Japan
TEL
078-785-1000
daizenhirata@gmail.com
Public contact
Name of contact person
| 1st name | Daizen |
| Middle name | |
| Last name | Hirata |
Organization
Sano hospital
Division name
Gastrointestinal Center, & Institute of Minimally-Invasive Endoscopic Care
Zip code
6550031
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Japan
TEL
078-785-1000
Homepage URL
daizenhirata@gmail.com
Sponsor or person
Institute
Sano hospital
Institute
Department
Personal name
Daizen Hirata
Funding Source
Organization
Sano hospital
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
Ethics Committee of Sano Hospital
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, 655-0031, Japan
Tel
078-785-1000
yonedarieko@gmail.com
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
| 2024 | Year | 06 | Month | 25 | 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
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062429
