UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027447 |
|---|---|
| Receipt number | R000031446 |
| Scientific Title | High resolution manometry with a small caliber scope for esophageal motility disorders |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2017/05/22 19:56:53 |
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Basic information
Public title
High resolution manometry with a small caliber scope for esophageal motility disorders
Acronym
High resolution manometry with a small caliber scope for esophageal motility disorders
Scientific Title
High resolution manometry with a small caliber scope for esophageal motility disorders
Scientific Title:Acronym
High resolution manometry with a small caliber scope for esophageal motility disorders
Region
| Japan |
Condition
Condition
esophageal motility disorders
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Secure the High resolution manometry (HRM) probe to the small caliber Esophagogastroduodenoscope with tape. After insert the endoscope into the stomach, we perform HRM.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of insertion of HRM probe into the stomach
Key secondary outcomes
Probe insertion time, Presence or absence of complications, etc
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The HRM probe inserted under the endoscope guide
Interventions/Control_2
The HRM probe inserted nasally as in the conventionally
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
1)Patients with suspected esophageal motility diisorders who visits our hospital.
2)Patients who consented to the participation in this research by written document
Key exclusion criteria
1)Patients under 20 years old, over 80 years old
2)Patients taking three or more medications such as anticoagulants and antiplatelets.
3)Patients suffering from severe hepatic / renal injury, heart disease
4)Patients judged to be unfit to participate in this study, by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiro Inoue, MD, PhD |
Organization
Showa University koto Toyosu Hospital
Division name
Digestive Disease Center
Zip code
Address
5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL
03-6204-6000
haruinoue777@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Sumi, MD |
Organization
Showa University koto Toyosu Hospital
Division name
Digestive Disease Center
Zip code
Address
5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL
03-6204-6000
Homepage URL
nrt24345@nifty.com
Sponsor or person
Institute
Showa University koto Toyosu Hospital, Digestive Disease Center
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2017 | Year | 06 | Month | 01 | 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
| 2016 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | 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
| 2017 | Year | 05 | Month | 22 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031446
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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