UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001909 |
|---|---|
| Receipt number | R000002320 |
| Scientific Title | manometry and impedance characteristics of esophageal motility disorders after pneumatic dilation |
| Date of disclosure of the study information | 2009/05/07 |
| Last modified on | 2019/01/09 13:25:38 |
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Basic information
Public title
manometry and impedance characteristics of esophageal motility disorders after pneumatic dilation
Acronym
manometry and impedance characteristics of esophageal motility disorders after pneumatic dilation
Scientific Title
manometry and impedance characteristics of esophageal motility disorders after pneumatic dilation
Scientific Title:Acronym
manometry and impedance characteristics of esophageal motility disorders after pneumatic dilation
Region
| Japan |
Condition
Condition
esophageal motility disorders
Classification by specialty
| Medicine in general | Gastroenterology | Endocrinology and Metabolism |
| Clinical immunology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare manometry and impedance of motility disorders befor and after pneumatic dilation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
impedance and manometry
esophageal balium exam
upper GI endoscope
questionaire
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
pneumatic dilation
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
esophageal motility disorders diagnosed by manometry
Key exclusion criteria
oerganic disorders of upper GI tract
too bad general conditions to exam
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | michio hongo |
Organization
TOHOKU UNIVERSITY OF MEDICINE
Division name
psychosomatic medicine
Zip code
Address
1-1 seiryo-machi,aoba,sendai 980-8574JAPAN
TEL
022-717-7327
m-hongo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | tomomi machida |
Organization
TOHOKU UNIVERSITY OF MEDICINE
Division name
psychosomatic medicine
Zip code
Address
1-1 seiryo-machi,aoba,sendai 980-8574JAPAN
TEL
022-717-7327
Homepage URL
momiyama1978@yahoo.co.jp
Sponsor or person
Institute
TOHOKU UNIVERSITY OF MEDICINE
department of psychosomatic medicine
Institute
Department
Personal name
Funding Source
Organization
TOHOKU UNIVERSITY OF MEDICINE
department of psychosomatic medicine
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
| 2009 | Year | 05 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 27 | Day |
Last modified on
| 2019 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002320
