UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023680 |
|---|---|
| Receipt number | R000027269 |
| Scientific Title | Diagnosis of esophageal achalasia by a novel endoscopic esophageal manometry method. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2020/11/06 19:18:04 |
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Basic information
Public title
Diagnosis of esophageal achalasia by a novel endoscopic esophageal manometry method.
Acronym
Efficiency of the novel endoscopic esophageal manometry method.
Scientific Title
Diagnosis of esophageal achalasia by a novel endoscopic esophageal manometry method.
Scientific Title:Acronym
Efficiency of the novel endoscopic esophageal manometry method.
Region
| Japan |
Condition
Condition
esophageal achalasia
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The manometry of esophageal pressure before and after the treatment of esophageal achalasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Esophageal pressure
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To measure the pressure of the lower esophageal sphincter by the upper gastrointestinal endoscopy mounting the EV balloon (Olympus).
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
Esophageal achalasia
Key exclusion criteria
Patient can not be obtained a informed consent.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okada |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
(+81)-86-235-7219
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YuusakuSugihara |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
(+81)-86-235-7219
Homepage URL
y.sugi117@gmail.com
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
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
| 2016 | Year | 09 | 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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 06 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 06 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027269
