UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024538 |
|---|---|
| Receipt number | R000028232 |
| Scientific Title | The next-generation technique of brain biopsy -Development of boring biopsy method- |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2022/10/31 10:17:20 |
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Basic information
Public title
The next-generation technique of brain biopsy -Development of boring biopsy method-
Acronym
boring biopsy
Scientific Title
The next-generation technique of brain biopsy -Development of boring biopsy method-
Scientific Title:Acronym
boring biopsy
Region
| Japan |
Condition
Condition
brain lesions
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the boring biopsy method for brain lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic efficiency and surgical complication rate
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 | Maneuver |
Interventions/Control_1
We investigate efficacy of new biopsy technique "boring biopsy method" and safety of special tool for it in the clinical application.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who has brain lesions which must be performed biopsy for histopathological confirmation are indicated in this study.
Key exclusion criteria
none
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Hongo |
Organization
Shinshu University School of Medicine
Division name
Department of Neurosurgery
Zip code
3908621
Address
Matsumoto
TEL
0263372690
khongo@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Ogiwara |
Organization
Shinshu University School of Medicine
Division name
Department of Neurosurgery
Zip code
3908621
Address
3-1-1 Asahi
TEL
0263372690
Homepage URL
togiwara@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
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
Department of Neurosurgery Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto
Tel
0263-37-2690
togiwara@shinshu-u.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
| 2016 | Year | 11 | Month | 01 | 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 | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2016 | Year | 10 | Month | 24 | Day |
Last modified on
| 2022 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028232
