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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004131
Receipt No. R000004961
Scientific Title Analsys of esophageal peristaltic movement by using 320 row Area Detector CT in healthy volunteers and patients with esophageal hiatus hernia
Date of disclosure of the study information 2010/08/30
Last modified on 2010/08/30

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Basic information
Public title Analsys of esophageal peristaltic movement by using 320 row Area Detector CT in healthy volunteers and patients with esophageal hiatus hernia
Acronym Analsys of esophageal peristaltic movement by using 320 row Area Detector CT
Scientific Title Analsys of esophageal peristaltic movement by using 320 row Area Detector CT in healthy volunteers and patients with esophageal hiatus hernia
Scientific Title:Acronym Analsys of esophageal peristaltic movement by using 320 row Area Detector CT
Region
Japan

Condition
Condition Esophageal hiatus hernia
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analsys of esophageal peristaltic movement healthy volunteers and patients with esophageal hiatus hernia
Basic objectives2 Others
Basic objectives -Others physiological function
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of esophageal peristaltic movement by using 320 row Area Detector CT images
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Healthy volunteers and patients with esophageal hiatus hernia
2)Subjects with written informed consent
Key exclusion criteria 1)Allergy for contrast medium
2)Past history of gastrectomy
3)The person who catch a clinically improper disease before study starting within 2 weeks
4)Severe diseases in hert,kidney,liver,nerve,digestive systems,or severe mental disorder
5)other not applicable person recognaized by a doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kinoshita
Organization Shimane University Faculty of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 89-1,Enya,Izumo,Shimane 693-8502,Japan
TEL 0853-20-2190
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Furuta
Organization Shimane University Faculty of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 89-1,Enya,Izumo,Shimane 693-8502,Japan
TEL 0853-20-2190
Homepage URL
Email

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Donation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2010 Year 08 Month 30 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
2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation of esophageal peristaltic movement by using 320 row Area Detector CT

Management information
Registered date
2010 Year 08 Month 30 Day
Last modified on
2010 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004961

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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