UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050102 |
|---|---|
| Receipt number | R000057080 |
| Scientific Title | Comparison of the Usefulness of EUS-FNA/B for Histological Diagnosis Using Sonotip Topgain and Acquire. |
| Date of disclosure of the study information | 2023/01/23 |
| Last modified on | 2023/01/23 03:42:25 |
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Basic information
Public title
Comparison of the Usefulness of EUS-FNA/B for Histological Diagnosis Using Sonotip Topgain and Acquire.
Acronym
Comparison of the Usefulness of EUS-FNA/B for Histological Diagnosis Using Sonotip Topgain and Acquire.
Scientific Title
Comparison of the Usefulness of EUS-FNA/B for Histological Diagnosis Using Sonotip Topgain and Acquire.
Scientific Title:Acronym
Comparison of the Usefulness of EUS-FNA/B for Histological Diagnosis Using Sonotip Topgain and Acquire.
Region
| Japan |
Condition
Condition
The patients requiring EUS-FNA/B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic ultrasound-assisted fine needle aspiration (EUS-FNA) is a standardized diagnostic method for pancreatic diseases. Recently, the Franseen needle puncture needle (Acquire; Boston Scientific) has been introduced to improve the specimen collection. On the other hand, the crowned tip of the Franseen needle makes it difficult to insert the needle into a lesion, and puncture techniques are required. A new puncture needle (Sonotip Topgain; Medicos Hirata Inc.) with the same Franseen needle shape but with a sharpened tip was introduced to the market, which reduced the difficulty of puncturing while maintaining the specimen collection rate. The following is a summary of the results of the study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Degree of organization frustration
Key secondary outcomes
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EUS-FNA/B performed once each on Sonotip Topgain and Acquire
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age18 to 95
2. Those planning EUS-FNA for pancreatic tumors, biliary tumors, lymph nodes, gastric submucosal tumors, etc.
3. Those who, after receiving a full explanation of their participation in this study, have obtained written consent
Key exclusion criteria
1. Plt 50000 mm3 PT(INR) 1.5
2. High risk bleeding for EUS FNA
3. Pregnant patient
4. Doctors doesn't approve.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hironao |
| Middle name | |
| Last name | Ookubo |
Organization
Juntendo Nerima hospital
Division name
Gastroenterology
Zip code
177-8521
Address
3-1-10 Takanodai Nerima-ku Tokyo, Japan
TEL
03-5923-3111
ytakasa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Takasaki |
Organization
Juntendo Nerima hospital
Division name
Gastroenterology
Zip code
177-8521
Address
3-1-10 Takanodai Nerima-ku Tokyo, Japan
TEL
03-5923-3111
Homepage URL
ytakasa@juntendo.ac.jp
Sponsor or person
Institute
Juntedo Nerima Hospital
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific, Medicos Hirata
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
Good clinical practice center
Address
3-1-3 Hongo Bunkyo-ku Tokyo, Japan
Tel
03-3813-3111
igakubu.rinri1@juntendo.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
| 2023 | Year | 01 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057080
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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