UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030280 |
|---|---|
| Receipt number | R000033544 |
| Scientific Title | Clinical trial of intracardiac probe |
| Date of disclosure of the study information | 2017/12/06 |
| Last modified on | 2018/06/08 13:33:47 |
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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
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
kazuki_kihara@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033544
