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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003388
Receipt No. R000004113
Scientific Title adequate imaging time for small bowel capsule endoscopy
Date of disclosure of the study information 2010/03/27
Last modified on 2012/10/27

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Basic information
Public title adequate imaging time for small bowel capsule endoscopy
Acronym Usefulness of RAPID Access real-time
Scientific Title adequate imaging time for small bowel capsule endoscopy
Scientific Title:Acronym Usefulness of RAPID Access real-time
Region
Japan

Condition
Condition small bowel diseases
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the analysis of the adequate imaging time for small bowel capsule endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes adequate imaging time for small bowel
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
Device,equipment
Interventions/Control_1 RAPID Access real-time was attached to the patient. At the 120 min after swallowing the capsule, if the capsule was still located in the stomach, 10mg of metoclopramide was given intramuscularly.
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 the patient who is suspected with small bowel disorder in the clinical practice.
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.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemi Goto
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 65 Tsurumai-Cho, Showa-Ku, Nagoya-Shi, Aichi-Ken
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masanao Nakamura
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 65 Tsurumai-Cho, Showa-Ku, Nagoya-Shi, Aichi-Ken
TEL
Homepage URL
Email makamura@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya 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
2010 Year 03 Month 27 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 Terminated
Date of protocol fixation
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2012 Year 10 Month 26 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 27 Day
Last modified on
2012 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004113

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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