UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011464
Receipt No. R000013415
Scientific Title Comparison of values obtained with a Japanese high resolution manometry (HRM) system and an American HRM system
Date of disclosure of the study information 2013/08/13
Last modified on 2019/09/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of values obtained with a Japanese high resolution manometry (HRM) system and an American HRM system
Acronym Comparison of values obtained with two high-resolution manometry systems
Scientific Title Comparison of values obtained with a Japanese high resolution manometry (HRM) system and an American HRM system
Scientific Title:Acronym Comparison of values obtained with two high-resolution manometry systems
Region
Japan

Condition
Condition Asymptomatic volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare values obtained with a Japanese HRM system and an American HRM system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences in integrated relaxation pressure values obtained with two HRM systems
Key secondary outcomes Differences in distal contractile integral, contractile front velocity, intra-bolus pressure and distal latency values obtained with two HRM systems

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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 Esophageal manometry will be performed with an American high resolusion manometry system (HRM) and then will be performed with a Japanese HRM again.
Interventions/Control_2 Esophageal manometry will be performed with a Japanese high resolusion manometry system (HRM) and then will be performed with an American HRM again.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Asymptomatic subjects
Key exclusion criteria Previous operations in upper GI tract or nasal cavity
Patients receiving medication for symptoms related to esophageal diseases such as heartburn or dysphagia
Patients receiving medication that may affect GI motility
Patients with diseases that may affect GI motility, such as diabetes mellitus, collagen diseases and neuromuscular diseases
Target sample size 105

Research contact person
Name of lead principal investigator
1st name Motoyasu
Middle name
Last name Kusano
Organization Gunma University Hospital
Division name Department of Endoscopy and Endoscopic surgery
Zip code 371-8511
Address 3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8137
Email mkusano@showa.gunma-u.ac.jp

Public contact
Name of contact person
1st name Shiko
Middle name
Last name Kuribayashi
Organization Gunma University Hospital
Division name Department of Gastroenterology
Zip code 371-8511
Address 3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8137
Homepage URL
Email shikokuri@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital, Department of Endoscopy and Endoscopic surgery
Institute
Department

Funding Source
Organization Star Medical, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Nippon Medical School Chiba Hokusoh Hospital
National Hospital Organization Numata National Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Gunma University Hospital
Address 3-39-15 Showa-machi, Maebashi, Gunma
Tel 027-220-8137
Email shikokuri@gunma-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 群馬大学医学部附属病院(群馬県)、日本医科大学千葉北総病院(千葉県)、独立行政法人国立病院機構沼田病院(群馬県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 103
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
2013 Year 07 Month 31 Day
Date of IRB
2013 Year 06 Month 26 Day
Anticipated trial start date
2013 Year 08 Month 15 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 12 Day
Last modified on
2019 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013415

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.