UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043951 |
|---|---|
| Receipt number | R000050194 |
| Scientific Title | The clinical trial for reduction of radiation exposure by adjusting fluoroscopy pulse rate during neuroendovascular surgery |
| Date of disclosure of the study information | 2021/04/17 |
| Last modified on | 2021/04/16 15:43:36 |
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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
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
takeshi.shimizu32@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Kansai Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050194
