UMIN-CTR Clinical Trial

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
Email	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
Email	togiwara@shinshu-u.ac.jp

Sponsor
Institute	Department of Neurosurgery Shinshu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028232