UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the usefulness of a new puncture needle (Acquire TM) in EUS-FNA.
Title of the study (Brief title)	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	AKANE YAMABE
Organization	Fukushima Medical University, Aizu Medical Center
Division name	Department of Gastroenterology
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	AKANE YAMABE
Organization	Fukushima Medical University, Aizu Medical Center
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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