UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016100 |
|---|---|
| Receipt number | R000018698 |
| Scientific Title | Evaluation of the effect of enhanced ultrasound for healthy colon |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2019/01/05 12:51:51 |
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Basic information
Public title
Evaluation of the effect of enhanced ultrasound for healthy colon
Acronym
Evaluation of the effect of enhanced ultrasound for healthy colon
Scientific Title
Evaluation of the effect of enhanced ultrasound for healthy colon
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takehiko Katsurada |
Organization
Hokkaido University Hospital
Division name
Division of Gastroenterology and Hepatorogy
Zip code
Address
N14,W5,Kita-ku,Sapporo,Hokkaido
TEL
011-716-1161
tkatsu@amber.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Midori Nishioka |
Organization
Hokkaido University Hospital
Division name
Institutional Review Board
Zip code
Address
Kita14 Nishi5, Kita-ku, Sapporo,Japan
TEL
011-706-7636
Homepage URL
crjimu@huhp.hokudai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018698
