UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020225
Receipt number R000023287
Scientific Title Fat removal capability of the Autotransfusion System
Date of disclosure of the study information 2015/12/18
Last modified on 2016/10/30 10:48:23

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Basic information

Public title

Fat removal capability of the Autotransfusion System

Acronym

Fat removal capability of the Autotransfusion System

Scientific Title

Fat removal capability of the Autotransfusion System

Scientific Title:Acronym

Fat removal capability of the Autotransfusion System

Region

Japan


Condition

Condition

Autologous blood recovery system

Classification by specialty

Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

assessment of the fat removal capability of the Autologous blood recovery system

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the amount of fat contained in the Autologous blood

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

operations to use the Autologous blood recovery system

Key exclusion criteria

none

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sato Hitoshi

Organization

yokohama city university hospital

Division name

Anesthesiology

Zip code


Address

3-9 fukuura kanazawaku yokohama

TEL

045-787-2918

Email

sjinkun@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sato Hitoshi

Organization

yokohama city university hospital

Division name

Anesthesiology

Zip code


Address

3-9 fukuura kanazawaku yokohama

TEL

045-787-2918

Homepage URL


Email

sjinkun@yokohama-cu.ac.jp


Sponsor or person

Institute

yokohama city university

Institute

Department

Personal name



Funding Source

Organization

yokohama city university

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


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

2015 Year 12 Month 18 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

Terminated

Date of protocol fixation

2015 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Research design:cross-sectional study
Way for subscription of patients:patients who are scheduled for elective surgery with autologous blood recovery system and write informed consent from December 18 2015.
Measurement parameters:the amount of fat contained in the blood collected from the operative field and the autologous blood.


Management information

Registered date

2015 Year 12 Month 16 Day

Last modified on

2016 Year 10 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023287


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name