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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034510
Receipt No. R000039345
Scientific Title Preventing migration of duodenal covered self-expandable metallic stent with an over-the-scope clip device
Date of disclosure of the study information 2018/10/15
Last modified on 2018/10/15

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Basic information
Public title Preventing migration of duodenal covered self-expandable metallic stent with an over-the-scope clip device
Acronym Feasibility of duodenal covered stent fixation
Scientific Title Preventing migration of duodenal covered self-expandable metallic stent with an over-the-scope clip device
Scientific Title:Acronym Feasibility of duodenal covered stent fixation
Region
Japan

Condition
Condition Malignant gastric outlet obstruction (GOO)
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Prevent migration of covered duodenal stent using over-the-scope clip device.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Migration rate of duodenal C-SEMS.
Key secondary outcomes Relapse rate of GOO symptoms
Success rate
Perforation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Attaching an OTSC device after duodenal C-SEMS placement to prevent migration
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 Patients who perform duodenal C-SEMS placement
Key exclusion criteria Pregnant woman
Patients who have esophageal varices and hemorrhagic disease
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuki Hori
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL +81-52-853-8211
Email yhori@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Hayashi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL +81-52-853-8211
Homepage URL http://ncu-cr.jp/patient
Email khayashi@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 15 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 15 Day
Last follow-up date
2023 Year 10 Month 15 Day
Date of closure to data entry
2023 Year 10 Month 15 Day
Date trial data considered complete
2023 Year 10 Month 20 Day
Date analysis concluded
2023 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 15 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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