UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013126 |
|---|---|
| Receipt number | R000015266 |
| Scientific Title | Optimal pretreatment for observing stomach lumen while under water using capsule endoscopy. |
| Date of disclosure of the study information | 2014/02/14 |
| Last modified on | 2014/06/28 12:39:11 |
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Basic information
Public title
Optimal pretreatment for observing stomach lumen while under water using capsule endoscopy.
Acronym
Optimal pretreatment for gastric capsule endoscopy.
Scientific Title
Optimal pretreatment for observing stomach lumen while under water using capsule endoscopy.
Scientific Title:Acronym
Optimal pretreatment for gastric capsule endoscopy.
Region
| Japan |
Condition
Condition
Helicobacter Pylori related gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the optimal pretreatment for observing stomach lumen while under water using capsule endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
1)Primary: Quality of pretreatment
A) Transparency of fluid in the stomach
B) Level of mucus and bubbles in the fluid
2)Second: Extensibility of the stomach
Safety
1) Adverse event
2) Symptoms
3) Physical examination
4) Physiological examination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
aa
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who fills everything the following
1)Patients of 20 yo or more, less than 65 yo.
2)Patients who gives written informed consent.
3)Patients who were judged as qualified subject with normal blood pressure/pulse rate.
4)Patients who were diagnosed whether Helicobacter pylori was positive or negative confirmed by urea breath test
Key exclusion criteria
1)Patients who has past history of allergy for Lidocaine
2)Patients who join other study
3)Patients who can not observe the rule of this study.
4)Pregnant females
5)Patient whom examination doctor judged improper as testee
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Irisawa |
Organization
Fukushima Medical University Aizu Medical Center.
Division name
Department of Gastroenterology
Zip code
Address
21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, 969-3492. Japan.
TEL
0242-75-2100
irisawa@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Irisawa |
Organization
Fukushima Medical University Aizu Medical Center.
Division name
Department of Gastroenterology
Zip code
Address
21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, 969-3492. Japan.
TEL
0242-75-2100
Homepage URL
irisawa@fmu.ac.jp
Sponsor or person
Institute
Souseikai medical corporation, Clinic HAKATA.
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
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
医療法人相生会 博多クリニック
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 14 | 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
| 2014 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 08 | 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
| 2014 | Year | 02 | Month | 10 | Day |
Last modified on
| 2014 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015266
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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