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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050194


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name