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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031598
Receipt No. R000036061
Scientific Title A study on the usefulness of a new puncture needle (Acquire TM) in EUS-FNA.
Date of disclosure of the study information 2018/03/05
Last modified on 2018/03/05

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Basic information
Public title A study on the usefulness of a new puncture needle (Acquire TM) in EUS-FNA.
Acronym A study on the usefulness of Acquire TM.
Scientific Title A study on the usefulness of a new puncture needle (Acquire TM) in EUS-FNA.
Scientific Title:Acronym A study on the usefulness of Acquire TM.
Region
Japan

Condition
Condition Gastroenterology
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the usefulness (AcquireTM collection rate, diagnostic ability, etc. of tissue specimen, etc.) of Equadrima on EUS-FNA in a subject whose stroke length is 10 mm or less.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A final diagnosis is made with a surgical specimen or follow-up observation for more than 3 months, and the coincidence rate with EUS-FNA diagnosis is evaluated.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 A patient with a stroke length of 10 mm or less in EUS-FNA.

Patient that exists on the image, transesophageal, stomach or duodenum and can be safely punctured using FNA needle.

Patients older than 20 years
Key exclusion criteria Case of 20 years old or younger

Informed consent can not be obtained

Other cases that the doctor in charge judged inappropriate as the subject
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name AKANE YAMABE
Organization Fukushima Medical University, Aizu Medical Center
Division name Department of Gastroenterology
Zip code
Address 21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Japan 969-3492
TEL 0242-75-2100
Email yamaaka0110@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name AKANE YAMABE
Organization Fukushima Medical University, Aizu Medical Center
Division name Department of Gastroenterology
Zip code
Address 21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Japan 969-3492
TEL 0242-75-2100
Homepage URL
Email yamaaka0110@yahoo.co.jp

Sponsor
Institute Fukushima Medical University, Aizu Medical Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 03 Month 05 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 Completed
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036061

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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