UMIN-CTR Clinical Trial

Basic information
Public title	The clinical trial for reduction of radiation exposure by adjusting fluoroscopy pulse rate during neuroendovascular surgery
Acronym	Reduction of radiation exposure by adjusting fluoroscopy pulse rate during neuroendovascular surgery
Scientific Title	The clinical trial for reduction of radiation exposure by adjusting fluoroscopy pulse rate during neuroendovascular surgery
Scientific Title:Acronym	Reduction of radiation exposure by adjusting fluoroscopy pulse rate during neuroendovascular surgery
Region	Japan

Condition
Condition	Cerebral aneurysm
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate whether using low pulse rate fluoroscopy can reduce the radiation exposure while maintaining safety during neuroendovascular surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dose area product, air karma
Key secondary outcomes	Preoperative complication (bleeding, infarction, aneurysm perforation)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Neuroendovascular surgery using low pulse rate fluoroscopy
Interventions/Control_2	Neuroendovascular surgery using standard pulse rate fluoroscopy
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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Cases for which neuroendovascular surgery is indicated
Key exclusion criteria	Cases in which neuroendovascular surgery was attempted but could not be achieved for reasons other than the procedure.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takuyu Middle name Last name Taki
Organization	Kansai Rosai Hospital
Division name	Neurosurgery
Zip code	565-8511
Address	3-1-69 Inabaso, Amagasaki city, Hyogo, Japan
TEL	06-6416-1221
Email	taki-takuyu@kansaih.johas.go.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Shimizu
Organization	Kansai Rosai Hospital
Division name	Neurosurgery
Zip code	565-8511
Address	3-1-69 Inabaso, Amagasaki city, Hyogo, Japan
TEL	06-6416-1221
Homepage URL
Email	takeshi.shimizu32@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Kansai Rosai Hospital
Institute
Department

Funding Source
Organization	Kansai Rosai Hospital
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	Kansai Rosai Hospital
Address	3-1-69 Inabaso, Amagasaki city, Hyogo, Japan
Tel	06-6416-1221
Email	takeshi.shimizu32@nsurg.med.osaka-u.ac.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	2021 Year 04 Month 17 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	Enrolling by invitation
Date of protocol fixation	2021 Year 01 Month 01 Day
Date of IRB	2021 Year 03 Month 05 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 16 Day
Last modified on	2021 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050194