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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029741
Receipt No. R000033978
Scientific Title Usefulness of Transesophageal Echocardiography Probe for the Diagnosis of Digestive Diseases
Date of disclosure of the study information 2018/01/01
Last modified on 2019/04/29

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Basic information
Public title Usefulness of Transesophageal Echocardiography Probe for the Diagnosis of Digestive Diseases
Acronym TEE-DD study
Scientific Title Usefulness of Transesophageal Echocardiography Probe for the Diagnosis of Digestive Diseases
Scientific Title:Acronym TEE-DD study
Region
Japan

Condition
Condition esopahgeal and paraesophageal diseases
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluated the usefulness of Transesophageal Echocardiography (TEE) in the esophageal and paraesophageal (lymph nodes, pancreas, liver, etc)diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences of the EUS and TEE images and concordance between TEE images and pathology
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 The use of transesophageal echocardiography probe for the diagnosis of digestive diseases
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
85 years-old >
Gender Male and Female
Key inclusion criteria Those who have esophageal or paraesophageal diseases which can be deteced by EUS.
Key exclusion criteria Severe complications
Severe mental disordor
Judement as being ineligible by the principal or subinvestigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshiki
Middle name
Last name Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560
TEL 052-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Ishikawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560
TEL 052-744-2602
Homepage URL
Email ishitaku@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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 Institutional Review Board of Nagoya University
Address 65 Tsurumai-cho, Showa-ku, Nagoya
Tel 0527441958
Email center@med.nagoya-u.ac.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
2018 Year 01 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 27 Day
Last modified on
2019 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033978

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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