UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006041 |
|---|---|
| Receipt number | R000007124 |
| Scientific Title | The investigation for the usefulness of the prototype endoscopy for the small intestine. |
| Date of disclosure of the study information | 2011/07/26 |
| Last modified on | 2012/11/20 17:57:06 |
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Basic information
Public title
The investigation for the usefulness of the prototype endoscopy for the small intestine.
Acronym
The investigation for the usefulness of the prototype endoscopy for the small intestine.
Scientific Title
The investigation for the usefulness of the prototype endoscopy for the small intestine.
Scientific Title:Acronym
The investigation for the usefulness of the prototype endoscopy for the small intestine.
Region
| Japan |
Condition
Condition
chronic pancreatitis
pancreatic cancer
malnutrition
gastrointestinal bleeding
ileus
obstructive jaundice and CBD stone in patients with surgially altered anatomies
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for the safety and efficacy of the prototype endoscopy for the small intestine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Safety(Complications)
Successful rate to the ligament of Treitz
Key secondary outcomes
Required time to the ligament of Treitz
Insertion length
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
The use of the prototype endoscopy for the small intestine(Olympus SIF-Y0002) without overtube.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient not applicable to the ineligible criteria of the upper GI endoscopy.(e.g. unstable vital sign)
Key exclusion criteria
Contraindication case.
(e.g. shock,perforation of the intestinal tract,strangulated ileus)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65 Tsuruma-Cho,Showa-Ku,Nagoya City
TEL
052-744-2602
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Nakamura |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65 Tsuruma-Cho,Showa-Ku,Nagoya City
TEL
052-744-2602
Homepage URL
y-naka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | 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
| 2011 | Year | 07 | Month | 25 | Day |
Last modified on
| 2012 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007124
