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Recruitment status Completed
Unique ID issued by UMIN UMIN000006041
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email y-naka@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007124


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