UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002003 |
|---|---|
| Receipt number | R000002438 |
| Scientific Title | Usefulness of a real-time capsule endoscopy for improvement of the image quality |
| Date of disclosure of the study information | 2009/05/29 |
| Last modified on | 2011/05/26 08:06:27 |
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Basic information
Public title
Usefulness of a real-time capsule endoscopy for improvement of the image quality
Acronym
Usefulness of a real-time capsule endoscopy for improvement of the image quality
Scientific Title
Usefulness of a real-time capsule endoscopy for improvement of the image quality
Scientific Title:Acronym
Usefulness of a real-time capsule endoscopy for improvement of the image quality
Region
| Japan |
Condition
Condition
small intestinal disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the utility of a real-time capsule endoscopy for the improvement of the image quality. According to the progress as viewed by the real-time monitor, on-demand medication, such as polyethylene glycol and metoclopramide are prescribed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
image quality of capsule endoscopy
Key secondary outcomes
completion rate to the cecum
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
A real-time viewer was attached to the patient. At the 60 min after swallowing the capsule, if the capsule was still located in the stomach, 10mg of metoclopramide was given intramuscularly, and then 500ml of polyethylene glycol solution was given to the patient. At the 60 min after swallowing the capsule, if the capsule reached the small bowel, 500ml of polyethylene glycol solution was given to the patient without administration of metoclopramide.
Interventions/Control_2
The capsule endoscopy was done without using a real-time viewer, and no preparation was done.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years-old and above
2) Patients who can provide written informed consent
Key exclusion criteria
a. The patients with dysphagia.
b. Pregnant or lactating women.
c. The patients who have history of the ileus or stricture or fistula of the intestine.
d. The patient with pacemaker or other medical electronic equipment.
e. A history of abdominal surgery.
f. The subject of any other clinical test/trial which will affect the results this study.
g. Can not comply with the study requirements or cannot follow instructions for the device.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
Homepage URL
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 29 | 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
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
| 2009 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 25 | Day |
Last modified on
| 2011 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002438
| 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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| Registered date | File name |
