UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028168 |
|---|---|
| Receipt number | R000032110 |
| Scientific Title | Study of safety and efficacy of Endoscopic Ultrasonography with Jelly injection |
| Date of disclosure of the study information | 2017/07/14 |
| Last modified on | 2019/07/12 11:37:54 |
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Basic information
Public title
Study of safety and efficacy of Endoscopic Ultrasonography with Jelly injection
Acronym
USJ Study
Scientific Title
Study of safety and efficacy of Endoscopic Ultrasonography with Jelly injection
Scientific Title:Acronym
USJ Study
Region
| Japan |
Condition
Condition
Gastrointestinal tract tumor and esophagogastric varix
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study on the safety and effectiveness of endoscopically injecting OS-1 jelly as a pretreatment for ultrasonic endoscopy for patients with or suspected of gastrointestinal tumor or esophageal varices .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre-treatment success rate of ultrasonic endoscopic examination
Key secondary outcomes
Serious adverse event
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
As a pretreatment for ultrasonic endoscope, inject up to 400 ml of OS-1 jelly in case of insufficient 5 minutes or 400 ml of water injection method.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Ultrasonic endoscopy with a probe method is planned with tumors of the esophagus, stomach, duodenum, small intestine, or large intestine, or with or suspected esophageal varices.
Key exclusion criteria
1) Cases with occlusion or high stenosis in the gastrointestinal tract.
2) Patients with a history of aspiration pneumonia or suspected of deteriorating swallowing function.
3) A case in which it is judged that the risk of endoscopic examination complicates gastrointestinal diseases such as intestinal perforation and acute pancreatitis and the effectiveness is exceeded.
4) Cases in which respiratory circulation status is not stable due to respiratory diseases, cardiovascular diseases, etc. and it is judged that it is difficult to perform endoscopic examination safely.
5) Other cases that the person in charge judged inappropriate to participate in this exam.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Takatori |
Organization
Kanazawa University Hospital
Division name
Gastroenterology
Zip code
Address
13-1,Takara-machi,Kanazawa
TEL
076-265-2235
takatori@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Terashima |
Organization
Kanazawa University Hospital
Division name
Gastroenterology
Zip code
Address
13-1,Takara-machi,Kanazawa
TEL
076-265-2235
Homepage URL
hajimetakatori@gmail.com
Sponsor or person
Institute
Kanazawa University Hospital, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital, Department of Gastroenterology
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
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
| 2017 | Year | 07 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 10 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032110
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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