UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027932 |
|---|---|
| Receipt number | R000031987 |
| Scientific Title | Resarch about near-infraed spectroscopy monitoring |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2017/06/26 10:44:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Resarch about near-infraed spectroscopy monitoring
Acronym
Resarch about NIRS
Scientific Title
Resarch about near-infraed spectroscopy monitoring
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ueyama |
Organization
Kansai Rosai Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-1-69, Inabaso, Amagasaki, Hyogo, 660-8511 JAPAN
TEL
06-6416-1221
ueyamahiroshi@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ueyama |
Organization
Kansai Rosai Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-1-69, Inabaso, Amagasaki, Hyogo, 660-8511 JAPAN
TEL
06-6416-1221
Homepage URL
ueyamahiroshi@me.com
Sponsor or person
Institute
Kansai Rosai Hospital
Institute
Department
Personal name
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)
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
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 |
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 | 05 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031987
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
