UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of intracardiac probe
Title of the study (Brief title)	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	Kazuki Kihara
Organization	Kochi Medical School
Division name	Second Department of Surgery
Address	Kohasu, Oko-cho, Kochi 783-8505, Japan.
TEL	0888802375
Email	kazuki_kihara@kochi-u.ac.jp

Public contact
Name of contact person	Kazuki Kihara
Organization	Kochi Medical School
Division name	Second Department of Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033544