UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effect of enhanced ultrasound for healthy colon
Title of the study (Brief title)	Evaluation of the effect of enhanced ultrasound for healthy colon
Region	Japan

Condition
Condition	healthy control
Classification by specialty	Gastroenterology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish enhanced ultrasound for healthy colon.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	analysis of blood stream of healthy colon by enhanced ultrasound (mean area under the curve max intensity, time to peak etc.)
Key secondary outcomes	healthy colon wall thickness (mm)

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	Medicine Device,equipment
Interventions/Control_1	Healthy control who give a written informed consent undergo contrast ultrasound by intravenous enhancer
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	1. Persons aged over 20 years-old who give a written informed consent. 2. Patients who admitted for colon polypectomy.
Key exclusion criteria	1. Persons who cannot undergo ultrasound safely. 2. Persons who have allergy for Sonazoid. 3. Persons who have allergy for eggs or egg products. 4. Persons who have shunts in heart or lungs. 5. Severe heart disease patients. 6. Severe pulmonary disease patients. 7. Patients who have acute disease that needs admission or within two weeks from discharge. 8. Patients who are disqualified for the study by their physicians.
Target sample size	20

Research contact person
Name of lead principal investigator	Takehiko Katsurada
Organization	Hokkaido University Hospital
Division name	Division of Gastroenterology and Hepatorogy
Address	N14,W5,Kita-ku,Sapporo,Hokkaido
TEL	011-716-1161
Email	tkatsu@amber.plala.or.jp

Public contact
Name of contact person	Midori Nishioka
Organization	Hokkaido University Hospital
Division name	Institutional Review Board
Address	Kita14 Nishi5, Kita-ku, Sapporo,Japan
TEL	011-706-7636
Homepage URL
Email	crjimu@huhp.hokudai.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 02 Day
Anticipated trial start date	2015 Year 01 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 02 Day
Last modified on	2019 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018698