UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019769 |
|---|---|
| Receipt number | R000022831 |
| Scientific Title | Efficacy and safety of endoscopic myotomy for esophageal motility disorder |
| Date of disclosure of the study information | 2015/11/12 |
| Last modified on | 2015/11/28 13:15:43 |
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Basic information
Public title
Efficacy and safety of endoscopic myotomy for esophageal motility disorder
Acronym
Efficacy and safety of endoscopic myotomy
Scientific Title
Efficacy and safety of endoscopic myotomy for esophageal motility disorder
Scientific Title:Acronym
Efficacy and safety of endoscopic myotomy
Region
| Japan |
Condition
Condition
esophageal motility disorder
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We prove efficacacy and safety of endoscopic myotomy for esophageal motility disorder.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Residual pressure of Lower Esophageal Sphincter by manometry(before and after treatmentuntil 3 month)
Key secondary outcomes
Questionnaire (Eckard's grading system), (F scale)
24h pH monitoring
Rate of proton Pomp Inhibitor internal use
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
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)15 years old<= 85 years old > male and female
2)patients diagnosed esophageal motility disorder
3)hospital patient
4)patients accepted agreement of this study.
Key exclusion criteria
1)impossible general anesthesia
2)patients undergone endoscopic treatment fo r esophageal disease
3)patients undergone radiation in area of esophagus
4)severe esophagitis
5)liver cirrhosis and esophageal varix
6)patients diagnosed inadequate for this study by doctor.
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Miyazaki |
Organization
Gunma University Graduate School
Division name
General surgical science
Zip code
Address
3-39-15 Showa-machi, Maebashi-shi, Gunma 371-8511
TEL
027-220-8224
tatsuyamiyazaki@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Miyazaki |
Organization
Gunma University Graduate School
Division name
General surgical science
Zip code
Address
3-39-15 Showa-machi, Maebashi-shi, Gunma 371-8511
TEL
027-220-8224
Homepage URL
tatsuyamiyazaki@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School general surgical science
Institute
Department
Personal name
Funding Source
Organization
Gunma University Graduate School general surgical science
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 | 11 | Month | 12 | 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 | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 30 | 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 | 11 | Month | 12 | Day |
Last modified on
| 2015 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022831
