UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058319 |
|---|---|
| Receipt number | R000066674 |
| Scientific Title | A Prospective Observational Study to Evaluate the Safety and Usefulness of Head-up Endoscopic Examination |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/30 14:47:20 |
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Basic information
Public title
Prospective Observational Study on Head-up Endoscopic Examination
Acronym
Study on Head-up Endoscopic Examination
Scientific Title
A Prospective Observational Study to Evaluate the Safety and Usefulness of Head-up Endoscopic Examination
Scientific Title:Acronym
Prospective Observational Study on Head-up Endoscopic Examination
Region
| Japan |
Condition
Condition
Upper Gastrointestinal Diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and outcomes of head-up endoscopic examination, including their association with background factors and endoscopic findings, with the expectation of contributing to the establishment of further diagnostic methods and treatment strategies for diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of complications due to endoscopic examination
Key secondary outcomes
Participant background (demographic information, medical history), physical findings (vitals, height/weight, adverse event confirmation, concomitant medication confirmation), clinical laboratory tests (hematological tests, blood biochemical tests), endoscopic findings, radiological examinations (CT), pathological findings, severity of complications (perforation, bleeding, stricture), presence/absence of additional treatment, medical expenses
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visit Keio University Hospital outpatient clinic for upper gastrointestinal endoscopy between the research implementation approval date and April 2030, and who provide free-willed informed consent for this study.
Key exclusion criteria
1 Cases with severe heart disease, 2 Minors or cases lacking capacity to consent due to dementia etc., 3 Other cases judged unsuitable for registration by the attending physician, 4 Cases where the research participant refuses to participate in this study after registration.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | Mizutani |
Organization
Keio University
Division name
Endoscopy-center
Zip code
160-8582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
marimizutani6@keio.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Mizutani |
Organization
Keio University
Division name
Endoscopy-Center
Zip code
160-8582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
marimizutani6@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel
03-3353-1211
n/a
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
| 2025 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The safety of head-up endoscopic examination (incidence of complications) will be the primary outcome, and the association with background factors, endoscopic findings, severity of complications, and medical expenses will be investigated as secondary outcomes
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066674
