UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Resarch about near-infraed spectroscopy monitoring
Title of the study (Brief title)	Resarch about NIRS
Region	Japan

Condition
Condition	Cerebrovascular disease
Classification by specialty	Anesthesiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether near infrared monitor can capture changes in oxygen saturation in the brain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	To nvestigate whether the near infrared monitor can capture the apparent oxygen saturation change induced by indocyanine green administered from the cerebral artery
Key secondary outcomes	To investigate what factors infulence the near-infrared monitor.

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	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Attach the sensor of the near infrared light monitor to the forehead part and the sensor for indocyanine green to the auricle part.Continuous administration of 0.5-2.0 mg of indocyanine green from the cerebral artery for few seconds in patients with cerebral angiography or intracerebral vascular treatment.Data of near infrared light sensor and indocyanine green sensor are recorded over time after indocyanine green administration. Recording time is within 5 minutes. Number of times: before and after cerebrovascular examination or treatment. Days: 1 day
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Person who receives examination or treatment because of cerebrovascular disease.
Key exclusion criteria	Person who has a history of indocyanin green allergy.
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroshi Ueyama
Organization	Kansai Rosai Hospital
Division name	Department of Anesthesiology
Address	3-1-69, Inabaso, Amagasaki, Hyogo, 660-8511 JAPAN
TEL	06-6416-1221
Email	ueyamahiroshi@me.com

Public contact
Name of contact person	Hiroshi Ueyama
Organization	Kansai Rosai Hospital
Division name	Department of Anesthesiology
Address	3-1-69, Inabaso, Amagasaki, Hyogo, 660-8511 JAPAN
TEL	06-6416-1221
Homepage URL
Email	ueyamahiroshi@me.com

Sponsor
Institute	Kansai Rosai Hospital
Institute
Department

Funding Source
Organization	Covidien JAPAN INC.
Organization
Division
Category of Funding Organization	Profit organization
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	関西労災病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 28 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 06 Month 23 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	2017 Year 06 Month 26 Day
Last modified on	2017 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031987