UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052212 |
|---|---|
| Receipt number | R000059591 |
| Scientific Title | Clinical usefulness of forward-viewing endoscopic ultrasonography in the field of digestive disease |
| Date of disclosure of the study information | 2023/09/14 |
| Last modified on | 2023/09/14 19:27:30 |
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Basic information
Public title
Clinical usefulness of forward-viewing endoscopic ultrasonography in the field of digestive disease
Acronym
Forward-viewing endoscopic ultrasonography for digestive disease
Scientific Title
Clinical usefulness of forward-viewing endoscopic ultrasonography in the field of digestive disease
Scientific Title:Acronym
Forward-viewing endoscopic ultrasonography for digestive disease
Region
| Japan |
Condition
Condition
Digestive disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical usefulness of forward-viewing endoscopic ultrasonography in the field of gastrointestinal diseases.
Basic objectives2
Others
Basic objectives -Others
Diagnostic capability, safety, clinical outcome, etc
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic result, Detection rate, Accuracy, Procedure time, adverse event, Accuracy, Clinical course, etc
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Endoscopic ultrasonography applicants
In good general condition
Key exclusion criteria
Poor general condition
No indication for endoscopy
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Akahoshi |
Organization
Aso Iizuka Hospital
Division name
Endoscopy Center
Zip code
820-8505
Address
Yoshio 3-83 Iizuka, Japan
TEL
0948-22-3800
kakahoshi2@aol.com
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Akahoshi |
Organization
Aso Iizuka Hospital
Division name
Endoscopy Center
Zip code
820-8505
Address
Yoshio3-83, Iizuka, Japan
TEL
0948-22-3800
Homepage URL
kakahoshi2@aol.com
Sponsor or person
Institute
Aso Iizuka Hospital
Institute
Department
Personal name
Funding Source
Organization
Aso Iizuka Hospital
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
Ethical board of Iizuka Hospital
Address
Yoshio3-83, Iizuka, Japan
Tel
0948 22 3800
rinri@aih-net.com
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
| 2023 | Year | 09 | Month | 14 | 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
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2031 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No adverse event to date
Prospective observational study
Retrospective observational study
Management information
Registered date
| 2023 | Year | 09 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059591
