UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016125 |
|---|---|
| Receipt number | R000018729 |
| Scientific Title | Per-oral endoscopic myotomy for achalasia |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2018/07/09 18:13:54 |
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Basic information
Public title
Per-oral endoscopic myotomy for achalasia
Acronym
Per-oral endoscopic myotomy
Scientific Title
Per-oral endoscopic myotomy for achalasia
Scientific Title:Acronym
Per-oral endoscopic myotomy
Region
| Japan |
Condition
Condition
achalasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of anterior myotomy, posterior myotomy, and long myotomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Relapse-free survival
Key secondary outcomes
Intra and post-treatment morbidity, success rate, symptom score, manometry findings
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
Per-oral endoscopic myotomy
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
informed consent
Key exclusion criteria
general condition is not favorable for general anesthesia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Sato |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Gastroenterology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
+81-25-223-6161
pyloki.sato@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Sato |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Gastroenterology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
+81-25-223-6161
Homepage URL
pyloki.sato@gmail.com
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29608597
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 | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2018 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018729
