UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041587 |
|---|---|
| Receipt number | R000047470 |
| Scientific Title | Evaluation of Physical Examination in the Detection of Arteriovenous Fistula Stenosis by deep learning |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2022/08/30 15:48:18 |
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Basic information
Public title
Evaluation of shunt physical examination by artificial intelligence
Acronym
Evaluation of shunt physical examination by AI
Scientific Title
Evaluation of Physical Examination in the Detection of Arteriovenous Fistula Stenosis by deep learning
Scientific Title:Acronym
Evaluation of Physical Examination in the Detection of Arteriovenous Fistula Stenosis by deep learning
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the accuracy of physical examination judgment by artificial intelligence in detecting artificial stenotic lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation with ultrasound evaluation items and shunt contrast results
Key secondary outcomes
Presence of intervention event
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
Inpatient dialysis patients from a dialysis center (Gamagori Municipal Hospital, Gamagori, Japan) during 2020-2022.
Key exclusion criteria
1) Patients on catheter dialysis
2) Patients with unstable circulatory dynamics
3) Patients deemed by the attending physician to be inappropriate for study participation on medical grounds
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Ota |
Organization
Gamagori City Hospital
Division name
Department of Nephrology
Zip code
443-8501
Address
1-1 Mukaida, Hirata-Chou, Gamagori, Aichi
TEL
81-533-66-2200
keke20keke20@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Ota |
Organization
Gamagori City Hospital
Division name
Department of Nephrology
Zip code
443-8501
Address
1-1 Mukaida, Hirata-Chou, Gamagori, Aichi
TEL
81-533-66-2200
Homepage URL
keke20keke20@yahoo.co.jp
Sponsor or person
Institute
Department of Nephrology, Gamagori City Hospital, Gamagori 443-8501, Japan
Institute
Department
Personal name
Funding Source
Organization
no
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
Gamagori City Hospital Ethics Committee
Address
Department of Nephrology, Gamagori City Hospital, Gamagori 443-8501, Japan
Tel
81-533-66-2200
test@test.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
蒲郡市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 01 | Day |
Other
Other related information
Record shunt auscultation sound, record shunt palpation results, record shunt ultrasound results, record shunt angiography results
Management information
Registered date
| 2020 | Year | 08 | Month | 28 | Day |
Last modified on
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047470
