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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029496
Receipt No. 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 2019/04/12

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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
Email 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
Email h-shigoka@oha.toho-u.ac.jp

Sponsor
Institute Toho University Ohashi Medical Center
Institute
Department

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
Email 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 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
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
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033671

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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