UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016512 |
|---|---|
| Receipt number | R000018943 |
| Scientific Title | Per-oral endoscopic esophageal myotomy for achalasia |
| Date of disclosure of the study information | 2015/02/15 |
| Last modified on | 2017/08/15 11:11:29 |
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Basic information
Public title
Per-oral endoscopic esophageal myotomy for achalasia
Acronym
Per-oral endoscopic esophageal myotomy for achalasia
Scientific Title
Per-oral endoscopic esophageal myotomy for achalasia
Scientific Title:Acronym
Per-oral endoscopic esophageal myotomy for achalasia
Region
| Japan |
Condition
Condition
esophageal achalasia
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the efficacy and less invasiveness of per-oral endoscopic myotomy for esophageal achalasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Relapse-free survival
Key secondary outcomes
Intra and post-treatment morbidity, success rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Per-oral endoscopic myotomy for esophageal achalasia with sever stenosis under general anethesia
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Esophageal achalasia with sever stenosis
Informed consent
Key exclusion criteria
Slight esophageal stenosis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinwa Tanaka MD, PhD |
Organization
Kobe University Hospital
Division name
Endoscopy
Zip code
Address
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL
078-382-6305
tanakas@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinwa Tanaka MD, PhD |
Organization
Kobe University Hospital
Division name
Endoscopy
Zip code
Address
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
TEL
078-382-6305
Homepage URL
tanakas@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology Kobe University 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
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
神戸大学医学部附属病院(兵庫)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 11 | Day |
Last modified on
| 2017 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018943
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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