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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002003
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002438

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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