UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035902 |
|---|---|
| Receipt number | R000039847 |
| Scientific Title | The safe and efficacy of forward viewing EUS for colorectal tumor |
| Date of disclosure of the study information | 2019/02/17 |
| Last modified on | 2019/02/17 15:51:35 |
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Basic information
Public title
The safe and efficacy of forward viewing EUS for colorectal tumor
Acronym
The safe and efficacy of forward viewing EUS for colorectal tumor
Scientific Title
The safe and efficacy of forward viewing EUS for colorectal tumor
Scientific Title:Acronym
The safe and efficacy of forward viewing EUS for colorectal tumor
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and efficacy of the ability to diagnosis for colorectal tumor by using forward viewing EUS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Matching of images obtained using forward viewing EUS and pathological evaluation for colorectal tumor
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 known or suspected colorectal tumor
2 colonoscopy scheduled or colonoscopy found colorectal tumor
3 complete informed consent
Key exclusion criteria
A. age limitations
B. allergy for egg
C. incomplete informed consent
D. pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yamamura |
Organization
Nagoya university hospital
Division name
Department of Endoscopy
Zip code
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 | |
| Middle name | |
| Last name | Masaya Esaki |
Organization
Nagoya university hospital
Division name
Department of Endoscopy
Zip code
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
Self funding
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
| 2019 | Year | 02 | Month | 17 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | 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
| 2019 | Year | 02 | Month | 17 | Day |
Last modified on
| 2019 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039847
