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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027607
Receipt No. 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

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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
Email 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
Email thara@iwakuni-nh.go.jp

Sponsor
Institute Iwakuni Clinical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031636

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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