UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034510 |
|---|---|
| Receipt number | 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 | 2021/10/18 08:09:42 |
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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 | Yasuki |
| Middle name | |
| Last name | Hori |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL
+81-52-853-8211
yhori@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Hayashi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL
+81-52-853-8211
Homepage URL
http://ncu-cr.jp/patient
khayashi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya Japan
Tel
81528587215
clinical_research@med.nagoya-cu.ac.jp
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 23 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 25 | Day |
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
| 2021 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039345
