UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055924 |
|---|---|
| Receipt number | R000063907 |
| Scientific Title | Prospective Study of the Upper Gastrointestinal Thin Endoscope EG-840TP in Emergency Upper Endoscopy for Non-Variceal Gastrointestinal Bleeding |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2026/03/01 11:04:22 |
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Basic information
Public title
Prospective Study of the Upper Gastrointestinal Thin Endoscope EG-840TP in Emergency Upper Endoscopy for Non-Variceal Gastrointestinal Bleeding
Acronym
EUE840TP
Scientific Title
Prospective Study of the Upper Gastrointestinal Thin Endoscope EG-840TP in Emergency Upper Endoscopy for Non-Variceal Gastrointestinal Bleeding
Scientific Title:Acronym
EUE840TP
Region
| Japan |
Condition
Condition
Non-Variceal Upper Gastrointestinal Bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To accumulate experience using the new EG-840TP thin treatment scope in emergency upper endoscopy for non-variceal upper gastrointestinal bleeding and to clarify its utility and limitations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes include the completion rate of hemostatic procedures using EG-840TP alone and the duration of the procedures.
Key secondary outcomes
Secondary outcomes include scope change rates, sedation and analgesia usage, and adverse events.
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 with symptoms of hematemesis or hemorrhage and suspected nonvariceal upper gastrointestinal bleeding.
Key exclusion criteria
Patients with esophageal or gastric variceal bleeding as a result of endoscopy .
Pregnant women or suspected pregnant women.
Patients who are deemed unsuitable by the physician in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Shimizu |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
983-0824
Address
5-22-1, Tsurugaya, Miyagino, Sendai, Miyagi, Japan
TEL
+81-22-252-1111
takeshi.shimizu@openhp.or.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Yamagata |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
983-0824
Address
5-22-1, Tsurugaya, Miyagino, Sendai, Miyagi, Japan
TEL
+81-22-252-1111
Homepage URL
y.gatataku@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
Adjust it ourself.
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
Sendai City Medical Center
Address
5-22-1, Tsurugaya, Miyagino, Sendai, Miyagi, Japan
Tel
+81-252-1111
k.tochikubo@openhp.or.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
| 2024 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective case collection for study subjects. To evaluate the usefulness and limitations of EG-840TP by analyzing lesion detection rate, procedure completion rate, scope change rate, sedative/analgesic use, and procedural adverse events.
Management information
Registered date
| 2024 | Year | 10 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063907
