UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053310 |
|---|---|
| Receipt number | R000060851 |
| Scientific Title | Verification of the performance of lesion detection assistance in computer aided diagnosis endoscopy |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/01/10 15:14:50 |
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Basic information
Public title
Verification of the performance of lesion detection assistance in computer aided diagnosis endoscopy
Acronym
Verification of the performance of lesion detection assistance in computer aided diagnosis endoscopy
Scientific Title
Verification of the performance of lesion detection assistance in computer aided diagnosis endoscopy
Scientific Title:Acronym
Verification of the performance of lesion detection assistance in computer aided diagnosis endoscopy
Region
| Japan |
Condition
Condition
Patients who underwent computer aided diagnosis endoscopy at our facility and polyps were detected
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify how quickly AI can detect and notify us of lesions that appear on endoscopic images. In addition, to compare whether the use of AI in combination with Linked Color Imaging (LCI), which has been shown to make lesions more visible in previous reports, improves their visibility (faster detection and notification).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from lesion appearance on endoscopic image to AI detection of lesion
Key secondary outcomes
Comparison of lesion detection time by lesion shape and color tone
Comparison of lesion detection time in case of AI endoscopy with LCI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Re-observation using Linked color imaging
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who are at least 20 years of age at the time consent is obtained
2. Patients who are able to perform the preparation as usual
3. Gender: any gender
4. Inpatient and outpatient: No questions asked
Key exclusion criteria
1. Patients undergoing emergency endoscopy
2. Patients with a history of colon resection or severe adhesion of the intestinal tract known in advance
3. Patients with chronic intestinal diseases such as inflammatory bowel disease
4. Patients with poor preparation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
097-586-6193
mizkaz0809@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
097-586-6193
Homepage URL
mizkaz0809@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Oita University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review board of Oita University, Faculty of medicine
Address
1-1, idaigaoka, Hasama, Yufu, Oita
Tel
097-586-5157
rinrikenkyu@oita-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 10 | 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
| 2023 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060851
