UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective Observational Study of Gastrointestinal Echocardiography in Patients Scheduled for Abdominal CT
Acronym	A study of gastrointestinal ultrasound in patients scheduled for abdominal CT
Scientific Title	A Prospective Observational Study of Gastrointestinal Echocardiography in Patients Scheduled for Abdominal CT
Scientific Title:Acronym	A study of gastrointestinal ultrasound in patients scheduled for abdominal CT
Region	Japan

Condition
Condition	Chronic Constipation
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare how accurate gastrointestinal echocardiography can be compared to CT findings
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Consistency of fecal reservoir findings in the colon and rectum on CT and echo 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Men and women over 20 years of age at the time of registration Patients who can perform gastrointestinal echocardiography within 1 hour before and after abdominal CT Patients who can give their consent to participate in the study
Key exclusion criteria	Patients who are deemed unsuitable for the subject by the physician
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Noboru Middle name Last name Misawa
Organization	Yokohama City University school of medicine
Division name	Department of gastroenterology and hepatology
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Email	misawa-ykh@umin.ac.jp

Public contact
Name of contact person	1st name Noboru Middle name Last name Misawa
Organization	Yokohama City University school of medicine
Division name	Department of gastroenterology and hepatology
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Homepage URL
Email	misawa-ykh@umin.ac.jp

Sponsor
Institute	Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization	Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
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	Yokohama City University Graduate School of Medicine
Address	3-9 Fukuura Kanazawa-ku Yokohama City
Tel	0453707627
Email	rinri@yokohama-cu.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	2020 Year 12 Month 09 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	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 17 Day
Date of IRB	2020 Year 08 Month 20 Day
Anticipated trial start date	2020 Year 09 Month 30 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 12 Month 09 Day
Last modified on	2020 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048741