UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044598 |
|---|---|
| Receipt number | R000050937 |
| Scientific Title | A prospective study on the clinical application of endoscopic balloon dilation by the side-by-side method |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2021/06/20 00:13:07 |
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Basic information
Public title
A prospective study on the clinical application of endoscopic balloon dilation by the side-by-side method
Acronym
EBD by side-by-side method
Scientific Title
A prospective study on the clinical application of endoscopic balloon dilation by the side-by-side method
Scientific Title:Acronym
EBD by side-by-side method
Region
| Japan |
Condition
Condition
benign stricture of esophagogastric junction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety of EBD by side-by-side method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complication just after the procedure
endoscopic findings, or X-ray findings
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The patients who receive EBD by side-by-side 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have benign stenosis of esophagogastric junction
20 years over
Key exclusion criteria
1: consent can not be obtained
2: pregnant
3: who has mental diseases or neurological disorders
4: who has severe respiratory disorders
5: who has severe heart failure, renal failure, hepatic failure
6: who cannot stop blood thinner
7: other inappropriate cases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Haruhiro |
| Middle name | |
| Last name | Inoue |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive disease center
Zip code
1358577
Address
5-1-38, Toyosu, Koto-ku, Tokyo
TEL
0362046000
haru.inoue@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Toshimori |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive disease center
Zip code
1358577
Address
5-1-38, Toyosu, Koto-ku, Tokyo
TEL
0362046000
Homepage URL
akikotoshimori@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Koto Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Koto Toyosu Hospital
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
Showa University Koto Toyosu Hospital
Address
5-1-38, Toyosu, Koto-ku, Tokyo
Tel
0362046000
th_irb@ofc.showa-u.ac.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
| 2021 | Year | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 20 | Day |
Last modified on
| 2021 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050937
| 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 |
