UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008603 |
|---|---|
| Receipt number | R000010110 |
| Scientific Title | Prospective study for the presence of small intestine lesion using capsule endoscopy in patient with immune fecal occult blood-positive. |
| Date of disclosure of the study information | 2012/08/02 |
| Last modified on | 2015/09/11 10:26:40 |
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Basic information
Public title
Prospective study for the presence of small intestine lesion using capsule endoscopy in patient with immune fecal occult blood-positive.
Acronym
Prospective study for the presence of small intestine lesion using capsule endoscopy in patient with immune fecal occult blood-positive.
Scientific Title
Prospective study for the presence of small intestine lesion using capsule endoscopy in patient with immune fecal occult blood-positive.
Scientific Title:Acronym
Prospective study for the presence of small intestine lesion using capsule endoscopy in patient with immune fecal occult blood-positive.
Region
| Japan |
Condition
Condition
Patient with immune fecal occult blood-positive
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation prospective for the presence of small intestine lesion using colonoscopy, upper endoscopy and capsule endoscopy in immune fecal occult blood-positive.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence of small intestine lesion in patient with immune fecal occult blood-positive.
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
Capsule endoscope
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)The patient's age is between 18 and 89 years old.
2)The patient who has diagnosis of immunity fecal occult blood-positive.
3)Outpatient or hospitalization.
4)Informed Consent.
Key exclusion criteria
1)At their own request of resignation or withdrawal of informed consent.
2)It was found that patients do not satisfy the criteria after entry.
3)Stop of this study.
4)Patients who are considered to be inapproriate by the investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakatsu Nakamura |
Organization
Kanazawa Medical University
Division name
Department of Gastroenterology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakatsu Nakamura |
Organization
Kanazawa Medical University
Division name
Department of Gastroenterology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Homepage URL
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa 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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 02 | 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
| 2012 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 02 | 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
| 2012 | Year | 08 | Month | 02 | Day |
Last modified on
| 2015 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010110
