UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016279 |
|---|---|
| Receipt number | R000018882 |
| Scientific Title | Feasibility study of endoscopic ultrasonography using small-diameter high frequency ultrasound miniature probe in gastroenterological diseases. |
| Date of disclosure of the study information | 2015/01/21 |
| Last modified on | 2019/08/03 06:36:53 |
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Basic information
Public title
Feasibility study of endoscopic ultrasonography using small-diameter high frequency ultrasound miniature probe in gastroenterological diseases.
Acronym
Feasibility study of endoscopic ultrasonography using small-diameter high frequency ultrasound miniature probe in gastroenterological diseases.
Scientific Title
Feasibility study of endoscopic ultrasonography using small-diameter high frequency ultrasound miniature probe in gastroenterological diseases.
Scientific Title:Acronym
Feasibility study of endoscopic ultrasonography using small-diameter high frequency ultrasound miniature probe in gastroenterological diseases.
Region
| Japan |
Condition
Condition
Gastroenterological diseases(surgical specimens and endoscopic resection specimens)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To show the feasibility of endoscopic ultrasonography using small-diameter high frequency ultrasound miniature probe,by using a surgical specimens, and by performing a comparison with conventional probe and with pathology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the spatial resolution of small diameter high-frequency probe image by comparing with pathology.
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
･the case of surgical or endoscopic resection in the patients who underwent preoperative examination in our department due to gastroenterological diseases.
･the case obtained a consent to the observation in 20 years of age or older.
Key exclusion criteria
･the case which is not obtained a concent to the observation.
･the case seemed inappropriate to this study.
Target sample size
20
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
466-8550
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-2602
Homepage URL
kawai-m@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
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
Nagoya University
Address
above
Tel
above
kawai-m@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
| 2015 | Year | 01 | Month | 21 | 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
20
Results
We performed 10 cases of pancreatic surgical specimens.
Results date posted
| 2019 | Year | 08 | Month | 03 | Day |
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 | 11 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe the surgical specimen (surgical or endoscopic resection)by using a high-frequency small-diameter probe.
And we examine the usefulness and feasibility by comparing the image and pathological findings.
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018882
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
