UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032842 |
|---|---|
| Receipt number | R000037455 |
| Scientific Title | Evalution of Esophageal Motor Disorders in Diabetes Disease With High Resolution Manometry. |
| Date of disclosure of the study information | 2018/06/03 |
| Last modified on | 2020/07/01 15:26:39 |
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Basic information
Public title
Evalution of Esophageal Motor Disorders in Diabetes Disease With High Resolution Manometry.
Acronym
Evalution of Esophageal Motor Disorders in Diabetes Disease.
Scientific Title
Evalution of Esophageal Motor Disorders in Diabetes Disease With High Resolution Manometry.
Scientific Title:Acronym
Evalution of Esophageal Motor Disorders in Diabetes Disease.
Region
| Japan |
Condition
Condition
diabetic patients with dysphagia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of esophageal motor disorders in diabetic patients with dysphagia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
abnormal wave form with High Resolution Manometry
Key secondary outcomes
incidense rate, patient background, questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We provide an endoscope and high resolution manometry to diabetic patients with dysphagia.
Interventions/Control_2
We provide an endoscope and high resolution manometry to non diabetic patients with dysphagia.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with dysphagia
Key exclusion criteria
Cases with lack of patients consent
Cases with severe complications
Patients with malignancies
Cases with medical care histories relating to the esophagus or pharyngolarynx
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65, Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2172
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Muroi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65, Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2172
Homepage URL
muroi328@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology
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
Nagoya University Graduate School of Medicine Gastrointestinal science
Address
65 Tsurumai-cho, Showa-ku, Nagoya City
Tel
052-744-2172
muroi328@med.nagoya-u.ac.jp
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
| 2018 | Year | 06 | Month | 03 | 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
| 2018 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 02 | Day |
Last modified on
| 2020 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037455
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
