UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020609 |
|---|---|
| Receipt number | R000023686 |
| Scientific Title | The prospective study for diagnosing small bowel stenosis using small bowel endoscopy via oral route |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2021/05/10 09:12:32 |
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Basic information
Public title
The prospective study for diagnosing small bowel stenosis using small bowel endoscopy via oral route
Acronym
The prospective diagnostic study using small bowel endoscopy
Scientific Title
The prospective study for diagnosing small bowel stenosis using small bowel endoscopy via oral route
Scientific Title:Acronym
The prospective diagnostic study using small bowel endoscopy
Region
| Japan |
Condition
Condition
small bowel stenosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
diagnostic yield for small bowel stenosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic yield for small bowel stenosis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. 20 years old or more
2. getting written consent form
3. scheduled oral small bowel endoscopy for diagnosing small bowel stenosis
Key exclusion criteria
A) severe inflammation is complicated.
B) Pregnancy
C) Poor general condition
D) having severe baseline disease for heart, lung, kidney, or liver.
E) bradycardia or A-V block on ECG
F) previously parpicipated in this study
G) Doctor's decision
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanao Nakamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2172
makamura@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Yamamura |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2172
Homepage URL
makamura@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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
| 2016 | Year | 03 | Month | 01 | 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
| 2016 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective and observation study to check the clinical diagnosis using small bowel endoscopy
Management information
Registered date
| 2016 | Year | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023686
