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

Email

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

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name