UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031598 |
|---|---|
| Receipt number | 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 21:19:01 |
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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
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
yamaaka0110@yahoo.co.jp
Sponsor or person
Institute
Fukushima Medical University, Aizu Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036061
