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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030280
Receipt No. R000033544
Scientific Title Clinical trial of intracardiac probe
Date of disclosure of the study information 2017/12/06
Last modified on 2018/06/08

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Basic information
Public title Clinical trial of intracardiac probe
Acronym Clinical trial of intracardiac probe
Scientific Title Clinical trial of intracardiac probe
Scientific Title:Acronym Clinical trial of intracardiac probe
Region
Japan

Condition
Condition Diseases requiring cardiovascular surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and efficacy of intracardiac probe as a device for removing intracardiac air during cardiopulmonary bypass
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Occurrence cardiovascular damage
Key secondary outcomes Feasibility of air removal

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
Device,equipment
Interventions/Control_1 It is used when there is residual air in the heart during weaning from cardiopulmonary bypass.
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 Standard cardiaovasscular surgery requiring cardiac arrest using cardiopulmonary bypass
Key exclusion criteria Emergency surgery cases
Cases requiring selective cerebral perfusion
Case with a 30-day mortality rate of 10% or higher according to Japan score II
Cases with difficult aortic cross-clamping due to calcification
Case of coronary artery bypass surgery
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuki Kihara
Organization Kochi Medical School
Division name Second Department of Surgery
Zip code
Address Kohasu, Oko-cho, Kochi 783-8505, Japan.
TEL 0888802375
Email kazuki_kihara@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Kihara
Organization Kochi Medical School
Division name Second Department of Surgery
Zip code
Address Kohasu, Oko-cho, Kochi 783-8505, Japan.
TEL 0888802375
Homepage URL
Email kazuki_kihara@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

Funding Source
Organization Kochi Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 12 Month 06 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 Completed
Date of protocol fixation
2017 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 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 12 Month 06 Day
Last modified on
2018 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033544

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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