UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036213 |
|---|---|
| Receipt number | R000041253 |
| Scientific Title | Preliminary study of the forward-viewing endoscopic ultrasound Elastography for the colorectal disease |
| Date of disclosure of the study information | 2019/03/15 |
| Last modified on | 2019/03/15 17:15:18 |
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Basic information
Public title
Preliminary study of the forward-viewing endoscopic ultrasound Elastography for the colorectal disease
Acronym
EUS elastography for colorectal disease
Scientific Title
Preliminary study of the forward-viewing endoscopic ultrasound Elastography for the colorectal disease
Scientific Title:Acronym
EUS elastography for colorectal disease
Region
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
usefulness of EUS elastography for colorectal disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnosability of colorectal disease
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
EUS, which is approved for only upper GI diseases, is used for colorectal 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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 known or suspected colorectal disease
2 colonoscopy scheduled or colonoscopy found colorectal disease
Key exclusion criteria
A.age limitations
B.allergy for rubber
C.incomplete informed consent
D.pregnant
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Taketa |
| Middle name | |
| Last name | Yamamura |
Organization
Nagoya university hospital
Division name
Department of Endoscopy
Zip code
4668550
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL
0527412172
tyamamu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Esaki |
Organization
Nagoya university hospital
Division name
Department of Endoscopy
Zip code
4668550
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL
0527412172
Homepage URL
em6089@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Endoscopy, Nagoya university hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Endoscopy, Nagoya university hospita
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
Institution Review Board of Nagoya university
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
Tel
0527442479
ethics@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
| 2019 | Year | 03 | Month | 15 | 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
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 29 | Day |
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
| 2019 | Year | 03 | Month | 15 | Day |
Last modified on
| 2019 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041253
