UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017910 |
|---|---|
| Receipt number | R000020757 |
| Scientific Title | Evaluation of the healing process speed of gastric artificial ulcers after endoscopic submucosal dissection with Vonoprazan Fumarate |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2015/06/15 19:23:49 |
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Basic information
Public title
Evaluation of the healing process speed of gastric artificial ulcers after endoscopic submucosal dissection with Vonoprazan Fumarate
Acronym
Evaluation of the healing process speed of gastric artificial ulcers after endoscopic submucosal dissection with Vonoprazan Fumarate
Scientific Title
Evaluation of the healing process speed of gastric artificial ulcers after endoscopic submucosal dissection with Vonoprazan Fumarate
Scientific Title:Acronym
Evaluation of the healing process speed of gastric artificial ulcers after endoscopic submucosal dissection with Vonoprazan Fumarate
Region
| Japan |
Condition
Condition
Gastric neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the healing process speed of gastric artificial ulcers after endoscopic submucosal dissection with Vonoprazan Fumarate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of Scar stage in gastric artifical ulcer after ESD
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Take of Vonoprazan Fumarate
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed gastric adenoma or gastric cancer estimated as clinical stage IA endoscopically/Physicalstatus;0-2/Accepted to enrollment and registration for this prospective study
Key exclusion criteria
Subject with difficult agreement of enrollment and registration for this prospective study/Ineligible subjects certified by doctors
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumi Mashimo |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gastroenterology
Zip code
Address
1397-1 Yamane,Hidaka-shi,Saitama,Japan
TEL
042-984-4111
ymashimo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Mashimo |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gastroenterology
Zip code
Address
1397-1 Yamane,Hidaka-shi,Saitama,Japan
TEL
042-984-4111
Homepage URL
ymashimo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2015 | Year | 06 | Month | 15 | 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
| 2015 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 15 | Day |
Last modified on
| 2015 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020757
| 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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| Registered date | File name |
