UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029496 |
|---|---|
| Receipt number | R000033671 |
| Scientific Title | Management of inoperable malignant gastric outlet obstructions with WallFlex Duodenal Soft stent: a multicentre prospective study. |
| Date of disclosure of the study information | 2017/10/11 |
| Last modified on | 2023/04/17 08:09:49 |
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Basic information
Public title
Management of inoperable malignant gastric outlet obstructions with WallFlex Duodenal Soft stent: a multicentre prospective study.
Acronym
Efficacy and Safety of WallFlex Duodenal Soft for GOO
Scientific Title
Management of inoperable malignant gastric outlet obstructions with WallFlex Duodenal Soft stent: a multicentre prospective study.
Scientific Title:Acronym
Efficacy and Safety of WallFlex Duodenal Soft for GOO
Region
| Japan |
Condition
Condition
Inoperable malignant gastric outlet obstruction (GOO)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical efficacy and safety of WallFlex Duodenal Soft stent in patients with inoperable GOO
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical success: Proportion of patients with 1 point of greater improvement of GOOSS score
Key secondary outcomes
(1) Technical success
(2) Stent dysfunction
(3) Adverse events (exc. stent dysfunction)
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
WallFlex Duodenal Soft stent is used for patients with symptomatic inoperable malignant GOO
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) Patients aged 20 or older
(2) Inoperable malignant gastric outlet obstruction
(3) Provision of consent on the use of WallFlex Duodenal Soft stent
(4) Provision of informed consent on partcipation to the present study
Key exclusion criteria
(1) Contraindicaion for endoscopic procedure
(2) Patients who were not considered appropriate participants ot the present study
(3) Patients with too tight stricture to bebe traversed by accessory devices.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shigoka |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
153-8515
Address
2-22-36 Ohashi Meguro-ku Tokyo
TEL
03-3468-1251
h-shigoka@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shigoka |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
153-8515
Address
2-17-6 Ohashi Meguro-ku Tokyo
TEL
03-3468-1251
Homepage URL
h-shigoka@oha.toho-u.ac.jp
Sponsor or person
Institute
Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Ohashi Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Boston Scientific
IRB Contact (For public release)
Organization
IRB of Toho University Ohashi Medical Center
Address
2-22-36 Ohashi Meguro-ku Tokyo
Tel
03-3468-1251
secretary@oha.toho-u.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
| 2017 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
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
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033671
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
