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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038076
Receipt No. R000043395
Scientific Title Measurement of radiation dose of the patient with radiophotoluminescence dosimeter in neuro angiography
Date of disclosure of the study information 2020/04/01
Last modified on 2020/09/24

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Basic information
Public title Measurement of radiation dose of the patient in neuro angiography
Acronym Measurement of radiation dose of the patient in neuro angiography
Scientific Title Measurement of radiation dose of the patient with radiophotoluminescence dosimeter in neuro angiography
Scientific Title:Acronym Measurement of radiation dose of the patient with radiophotoluminescence dosimeter in neuro angiography
Region
Japan

Condition
Condition cerebral aneurysm, cerebral arteriovenous malformation, dural cerebral arteriovenous fistula etc.
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Estimation of radiation dose of the patients in cases of neurointerventional radiology
Basic objectives2 Others
Basic objectives -Others Estimation of skin doses and bilatrral lens doses
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Estimation of skin doses and lens doses performed neurointerventional radiology
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Setting of exclusive dosimerty cap
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients scheduled to undergo neurointerventional radiology
2) Age is 20 years or older
3) Any gender
Key exclusion criteria Pediatric patient
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Watarou
Middle name
Last name Tsuruta
Organization Toranomon Hospital
Division name Department of Endovascular Neurosurgery
Zip code 105-8470
Address 2-2-2 Toranomon, Minato, Tokyo
TEL 03-3588-1111
Email wataro@cf6.so-net.ne.jp

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Kawauchi
Organization Toranomon Hospital
Division name Department of Radiology
Zip code 105-8470
Address 2-2-2 Toranomon, Minato, Tokyo
TEL 03-3588-1111
Homepage URL
Email shibaken.shatle@kjd.biglobe.ne.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

Funding Source
Organization none
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 Toranomon Hospital
Address 2-2-2 Toranomon, Minato, Tokyo
Tel 03-3588-1111
Email chiken-jim2@toranomon.gr.jp

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
2020 Year 04 Month 01 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
2019 Year 09 Month 21 Day
Date of IRB
2020 Year 05 Month 14 Day
Anticipated trial start date
2020 Year 05 Month 15 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
2022 Year 09 Month 30 Day
Date trial data considered complete
2022 Year 09 Month 30 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 09 Month 21 Day
Last modified on
2020 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043395

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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