UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of neuroendoscopic surgery for neurosugical diseases
Title of the study (Brief title)	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	Fuminari Komatsu
Organization	Tokai University Hachioji Hospital
Division name	Neurosurgery
Address	1838 Ishikawa-machi, Hachioji, Tokyo, Japan
TEL	042-639-1111
Email	fuminarikomatsu@gmail.com

Public contact
Name of contact person	Fuminari Komatsu
Organization	Tokai University Hachioji Hospital
Division name	Department of Neurosurgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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