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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022625
Receipt No. R000026081
Scientific Title Evaluation of neuroendoscopic surgery for neurosugical diseases
Date of disclosure of the study information 2016/06/06
Last modified on 2017/12/11

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Basic information
Public title Evaluation of neuroendoscopic surgery for
neurosugical diseases
Acronym neuroendoscopic surgery for neurosugical
diseases
Scientific Title Evaluation of neuroendoscopic surgery for
neurosugical diseases
Scientific Title:Acronym neuroendoscopic surgery for neurosugical
diseases
Region
Japan

Condition
Condition brain tumor, traumatic intracranial hemorrhage, skull base fracture, intracranial infection
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of surgical effect by neuroendoscopy for brain tumor, traumatic intracranial hemorrhage, skull base fracture, and intracranial infection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes clinical symptom, surgical complication, neuroimaging
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 neuroendoscopic surgery
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
85 years-old >=
Gender Male and Female
Key inclusion criteria need of surgical management
Key exclusion criteria diffucult hemostasis under endoscopic surgery
need of external decompression
other inappropriate cases
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuminari Komatsu
Organization Tokai University Hachioji Hospital
Division name Neurosurgery
Zip code
Address 1838 Ishikawa-machi, Hachioji, Tokyo, Japan
TEL 042-639-1111
Email fuminarikomatsu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Fuminari Komatsu
Organization Tokai University Hachioji Hospital
Division name Department of Neurosurgery
Zip code
Address 1838 Ishikawa-machi, Hachioji, Tokyo, Japan
TEL 042-639-1111
Homepage URL
Email fuminarikomatsu@gmail.com

Sponsor
Institute Department of Neurosurgery, Tokai University School of Medicine, Kanagawa, Japan
Institute
Department

Funding Source
Organization Department of Neurosurgery, Tokai University School of Medicine, Kanagawa, Japan
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
Email

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 06 Month 06 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 06 Day
Last modified on
2017 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026081

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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