UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027607 |
|---|---|
| Receipt number | R000031636 |
| Scientific Title | Mobile interpretation using smartphone: a prospective study in detectability of CBD stone on Computed Tomography |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2017/06/19 09:53:34 |
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Basic information
Public title
Mobile interpretation using smartphone:
a prospective study in detectability of CBD stone on Computed Tomography
Acronym
Mobile interpretation using smartphone:
a prospective study in detectability of CBD stone on Computed Tomography
Scientific Title
Mobile interpretation using smartphone:
a prospective study in detectability of CBD stone on Computed Tomography
Scientific Title:Acronym
Mobile interpretation using smartphone:
a prospective study in detectability of CBD stone on Computed Tomography
Region
| Japan |
Condition
Condition
CBD stone
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To invastigate the detectability of CBD stone on MDCT using smartdevice by in home radiologist compare to using dedicated high resolution dysplay.
Basic objectives2
Others
Basic objectives -Others
Non-inferiority
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis of CBD stone positive or negative.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
who performed CT and ERCP in our hospital when suspected acute cholecystitis and cholangitis within 3 month after CT exam.
Key exclusion criteria
excludes patients who performed ERCP/EST before 3 month ago and Billorth-2 or Rouy-Y operation performed.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Hara |
Organization
Iwakuni Clinical Center
Division name
Department of Radiology
Zip code
Address
Atago-cho1-1-1,Iwakuni City,Yamaguchi pref.Japan
TEL
0827-34-1000
thara@iwakuni-nh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Hara |
Organization
Iwakuni Clinical Center
Division name
Department of Radiology
Zip code
Address
Atago-cho1-1-1,Iwakuni City,Yamaguchi pref.Japan
TEL
0827-34-1000
Homepage URL
thara@iwakuni-nh.go.jp
Sponsor or person
Institute
Iwakuni Clinical Center
Institute
Department
Personal name
Funding Source
Organization
Iwakuni Clinical Center
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
Address
Tel
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
| 2017 | Year | 07 | Month | 07 | 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
| 2017 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
(prospective Non-inferiority study)
July7 2017-June 30 2018
All registered cases meeting selection criteria.
Primary outcomes
CT Diagnosis of CBD stone positive or negative.
Management information
Registered date
| 2017 | Year | 06 | Month | 02 | Day |
Last modified on
| 2017 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031636
