UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036111 |
|---|---|
| Receipt number | R000041137 |
| Scientific Title | Intraoperative neurophysiology for stereotactic biopsy of the brain/brainstem tumor |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2020/03/06 15:03:10 |
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Basic information
Public title
Intraoperative neurophysiology for stereotactic biopsy of the brain/brainstem tumor
Acronym
Stereotactic biopsy of the brain/brainstem tumor
Scientific Title
Intraoperative neurophysiology for stereotactic biopsy of the brain/brainstem tumor
Scientific Title:Acronym
Stereotactic biopsy of the brain/brainstem tumor
Region
| Japan |
Condition
Condition
Brain/brainstem tumors
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To perform stereotactic biopsy of the brain/brainstem tumor safely under intraoperative neurophysiological procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety of the stereotactic biopsy surgery
Newly developed neurological deficit within 24 hours after the surgery is evaluated.
Key secondary outcomes
Functional localization of the brain/brainstem structures
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
During the stereotactic surgery, critical neural structures (corticospinal/corticobulbar tracts, cranial motor/sensory nuclei, and others) are mapped/localized by electrical stimulation through the surgical tract.
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
Brain/brainstem tumors subjected for the stereotactic biopsy surgery
Key exclusion criteria
Open cranial surgery
Patients with hemorrhagic tendency
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhito Morota |
Organization
Kitasato University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
1-15-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa
TEL
042-778-8111
nobu.m01@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhito Morota |
Organization
Kitasato University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
1-15-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
nobuhito_morota@tmhp.jp
Sponsor or person
Institute
Department of Neurosurgery
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 31 | 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
0
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
Terminated
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041137
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