UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053693 |
|---|---|
| Receipt number | R000060649 |
| Scientific Title | Influence of fatigue and stress on endoscopy accuracy and its relationship to AI colonoscopy: a multicenter clinical trial |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2025/02/25 09:57:19 |
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Basic information
Public title
Influence of fatigue and stress on endoscopy accuracy and its relationship to AI colonoscopy: a multicenter clinical trial
Acronym
FAST-C trial
Scientific Title
Influence of fatigue and stress on endoscopy accuracy and its relationship to AI colonoscopy: a multicenter clinical trial
Scientific Title:Acronym
FAST-C trial
Region
| Japan |
Condition
Condition
colonic polyps
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether the use of artificial intelligence (AI) increases the detection of colorectal polyps in lower gastrointestinal endoscopy.
Basic objectives2
Others
Basic objectives -Others
To investigate whether the AI system can reduce the endoscopist's examination accuracy under different fatigue levels and stress conditions.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
MAP (mean number of adenoma per procedure) between the two AI and non-AI groups
Key secondary outcomes
1. MAP and MPP (mean polyps detected per procedure) in the state of excessive fatigue
2. MAP and MPP under high stress conditions
3. MAP and MPP in over-fatigued and high-stress conditions
4. consideration of ADR and PDR
5. Examination of changes in fatigue and stress levels before and after the test
6. Examination by years of experience of the practitioner
7. examination time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Group undergoing routine lower gastrointestinal endoscopy with AI
Interventions/Control_2
Group undergoing routine lower gastrointestinal endoscopy without AI
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
Patients scheduled for routine lower gastrointestinal endoscopy
Patients who have received a full explanation of the situation from the attending physician regarding the contents of this study and have obtained consent
Key exclusion criteria
Patients with a history of colorectal resection
Patients with inadequate observation due to poor pretreatment
Patients with inflammatory bowel disease, familial adenomatous colorectal adenomatosis, or other polyposis
Patients with difficulty in deep insertion
Cases of gastrointestinal bleeding requiring endoscopic hemostasis
Other cases judged by the examiner to be unsuitable for a safe examination method
Cases in which consent for the study cannot be obtained.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kensei |
| Middle name | |
| Last name | Ohtsu |
Organization
Tobata Kyoritsu Hospital
Division name
Department of Gastroenterology
Zip code
804-0093
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu, Fukuoka, Japan
TEL
093-871-5421
k.ohtsu0120@gmail.com
Public contact
Name of contact person
| 1st name | Kensei |
| Middle name | |
| Last name | Ohtsu |
Organization
Tobata Kyoritsu Hospital
Division name
Department of gastroenterology
Zip code
804-0093
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu, Fukuoka, Japan
TEL
093-871-5421
Homepage URL
k.ohtsu0120@gmail.com
Sponsor or person
Institute
Tobata Kyoritsu Hospital
Institute
Department
Personal name
Kensei Ohtsu
Funding Source
Organization
Tobata Kyoritsu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saga University Hospital, Fukuoka University Chikushi Hospital, University of Miyazaki Hospital, University of the Ryukyus Hospital, Kyushu University Hospital, Kumamoto University Hospital, Kagoshima University Hospital, Hospital of the University of Occupational and Environmental Health, Oita University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoaikai Healthcare Corporation Tobata Kyoritsu Hospital Ethics Review Committee
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu, Fukuoka, Japan
Tel
093-871-5421
sinryou@kyoaikai.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 | 03 | 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
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060649
