UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055053 |
|---|---|
| Receipt number | R000062779 |
| Scientific Title | Clinical Evaluation of the Use of an Artificial Intelligence-based Application for Assessment of Pre-Colonoscopy Bowel Preparation : Multicenter Observational Study. |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/03/07 19:47:16 |
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Basic information
Public title
Clinical Evaluation of the Use of an Artificial Intelligence-based Application for Assessment of Pre-Colonoscopy Bowel Preparation : Multicenter Observational Study.
Acronym
Studies of the use of an AI-based app for pre-colonoscopy bowel preparation.
Scientific Title
Clinical Evaluation of the Use of an Artificial Intelligence-based Application for Assessment of Pre-Colonoscopy Bowel Preparation : Multicenter Observational Study.
Scientific Title:Acronym
Studies of the use of an AI-based app for pre-colonoscopy bowel preparation.
Region
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the Usefulness of Using an AI Decision Application in the preparation of Colonoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of bowel cleansing using Aronchick scale.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient undergoing colonoscopy as an outpatient.
Key exclusion criteria
Patients undergoing colonoscopy without pretreatment.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Shouko |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Optical Medical Treatment Department
Zip code
060-8648
Address
North 14,West 5,Kita-ku,Sapporo,Hokkaido,Japan
TEL
011-716-1161
onoshouko@gmail.com
Public contact
Name of contact person
| 1st name | Shouko |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Optical Medical Treatment Department
Zip code
060-8648
Address
North 14,West 5,Kita-ku,Sapporo,Hokkaido,Japan
TEL
011-716-1161
Homepage URL
onoshouko@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
None
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
Hokkaido University Hospital
Address
North 14,West 5,Kita-ku,Sapporo,Hokkaido,Japan
Tel
011-716-1161
onoshouko@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 | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients undergoing colonoscopy at the relevant facility during the follow-up period will be eligible for observation.
Management information
Registered date
| 2024 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062779
