UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052444 |
|---|---|
| Receipt number | R000059859 |
| Scientific Title | Evaluating False-Positive Detection in a Computer-Aided Detection System for Colonoscopy |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2024/10/09 16:54:14 |
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Basic information
Public title
Evaluating False-Positive Detection in a Computer-Aided Detection System for Colonoscopy
Acronym
false-positive study
Scientific Title
Evaluating False-Positive Detection in a Computer-Aided Detection System for Colonoscopy
Scientific Title:Acronym
false-positive study
Region
| Japan |
Condition
Condition
polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the rate and causes of FP using CADe before and after an update designed to reduce FP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of FP per colonoscopy
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
consecutive CADe assisted colonoscopy videos recorded
Key exclusion criteria
improper video data
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | taishi |
| Middle name | |
| Last name | okumura |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
81-55-989-5222
javier.thierry@gmail.com
Public contact
Name of contact person
| 1st name | taishi |
| Middle name | |
| Last name | okumura |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
81-55-989-5222
Homepage URL
javier.thierry@gmail.com
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel
055-989-5222
irb@scchr.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
| 2023 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jgh.16491
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jgh.16491
Number of participants that the trial has enrolled
191
Results
The mean number of FPs and median ET per colonoscopy were significantly lower in the post-update group than those in the pre-update group. Mucosal tags, bubbles, and folds had the strongest association with decreased FP post-update.
Results date posted
| 2024 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patient and procedural characteristics were comparable between the two groups.
Participant flow
The CADe was used in 191 ofthese cases, and video was recorded (94 in the pre-update group and 97 in the post-update group) involving three non-expert and five expert endoscopists were recorded. Six videos were excluded from the analysis because they were not properly recorded or contained no sound. PSM was conducted using eight factors, after which there were 146 colonoscopy videos (73 in each group).
Adverse events
Nothing in particular
Outcome measures
The primary outcome measure was the number ofFPs per colonoscopy. Secondary outcome measures included the number ofFPs per minute, excessive time spent by the endoscopists on FP (ET), causes ofFP, number of true positives (TP), ADR, polyp detection rate (PDR), and number of adenomas per colonoscopy (APC).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059859
