UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004954 |
|---|---|
| Receipt number | R000005893 |
| Scientific Title | Study on the efficacy of CT enteroclysis on patients with small intestinal diseases: comparison with enteroclysis or double-balloon enteroscopy or capsule endoscopy |
| Date of disclosure of the study information | 2011/02/26 |
| Last modified on | 2012/08/31 19:58:57 |
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Basic information
Public title
Study on the efficacy of CT enteroclysis on patients with small intestinal diseases: comparison with enteroclysis or double-balloon enteroscopy or capsule endoscopy
Acronym
Study on the efficacy of CT enteroclysis on patients with small intestinal diseases
Scientific Title
Study on the efficacy of CT enteroclysis on patients with small intestinal diseases: comparison with enteroclysis or double-balloon enteroscopy or capsule endoscopy
Scientific Title:Acronym
Study on the efficacy of CT enteroclysis on patients with small intestinal diseases
Region
| Japan |
Condition
Condition
small intestinal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of CT enteroclysis on patients with small intestinal diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison with enteroclysis or double-ballon enteroscopy or capsule endoscopy
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CT enteroclysis and enteroclysis,
double-ballon enteroscopy,or capsule endoscopy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with confirmed or suspected small intestinal diseases
2.Signed informed consent forms are obtained by the patients
Key exclusion criteria
1.Patients who be with serious medical condition by any disease
2.Subjects whose eligibility for this trial is not appropriate by other reasons
3.Evidence of increased risk of bowel perforation by CT enteroclysis
4.Patients with intestinal perforation
5.Patients with bleeding tendency
6.Patients administering anti conaglant drugs
7.Patients with severe hepatic diseases
8.Patients with severe renal diseases
9.Patients with severe respiratory diseases
10.Patients with severe cardiac diseases
11.Pregnant or feeding women
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Haruma |
Organization
Kawasaki Medical School and Hospital
Division name
Gastroenterology Department of Internal Medicine
Zip code
Address
577 Matsushima, Kurashiki city, Okayama 710-0192, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Ishii |
Organization
Kawasaki Medical School and Hospital
Division name
Gastroenterology Department of Internal Medicine
Zip code
Address
577 Matsushima, Kurashiki city, Okayama 710-0192, JAPAN
TEL
086-462-1111
Homepage URL
manabuisii@niji.or.jp
Sponsor or person
Institute
Kawasaki Medical School and Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 02 | Month | 26 | 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
| 2011 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 25 | Day |
Last modified on
| 2012 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005893
