UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006130 |
|---|---|
| Receipt number | R000006108 |
| Scientific Title | Study on the radial localization of gastroesophageal acid exposure in the distal esophagus by fixing a novel 8-channel pH sensor catheter to the esophageal wall among healthy subjects and patients with gastroesophageal reflux disease |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2012/04/01 23:49:18 |
* 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
Study on the radial localization of gastroesophageal acid exposure in the distal esophagus by fixing a novel 8-channel pH sensor catheter to the esophageal wall among healthy subjects and patients with gastroesophageal reflux disease
Acronym
Study on radial localization of gastroesophageal acid reflux
Scientific Title
Study on the radial localization of gastroesophageal acid exposure in the distal esophagus by fixing a novel 8-channel pH sensor catheter to the esophageal wall among healthy subjects and patients with gastroesophageal reflux disease
Scientific Title:Acronym
Study on radial localization of gastroesophageal acid reflux
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal radial acid exposure in the distal esophagus of healthy volunteers and patients with gastroesophageal reflux disease
Basic objectives2
Others
Basic objectives -Others
physiology
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Percent time at pH <4, number of acid reflux episodes and acid clearance time obtained by intraesophageal pH monitoring during the 3-hour post-prandial period
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Healthy volunteers and patients with gastroesophageal reflux disease more than 18 years-old
2)Subjects with written informed consent
Key exclusion criteria
1)Allegy for lidocaine
2)Past history of gastrectomy
3)The person who catch a clinically improper disease before study starting within 2 weeks
4)Severe diseases in heart, kidney, liver, nerve, digestive system,or severe mental disorder
5)other not applicable person recognized by a doctor
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
89-1, Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2190
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Furuta |
Organization
Shimane University School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
89-1, Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2190
Homepage URL
kfuruta@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Donation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
島根大学医学部附属病院(島根県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 08 | 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
| 2011 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
prospective study
Management information
Registered date
| 2011 | Year | 08 | Month | 08 | Day |
Last modified on
| 2012 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006108
