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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027447
Receipt No. 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

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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
Last 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
Email haruinoue777@yahoo.co.jp

Public contact
1st 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
Email nrt24345@nifty.com

Sponsor
Institute Showa University koto Toyosu Hospital, Digestive Disease Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031446

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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