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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014804
Receipt No. R000017217
Scientific Title Assessment of availability of FloTrack SystemTM for postoperative management in gastrointestinal surgeries.
Date of disclosure of the study information 2014/08/09
Last modified on 2014/08/09

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Basic information
Public title Assessment of availability of FloTrack SystemTM for postoperative management in gastrointestinal surgeries.
Acronym Assessment of availability of FloTrack SystemTM for postoperative management in gastrointestinal surgeries.
Scientific Title Assessment of availability of FloTrack SystemTM for postoperative management in gastrointestinal surgeries.
Scientific Title:Acronym Assessment of availability of FloTrack SystemTM for postoperative management in gastrointestinal surgeries.
Region
Japan

Condition
Condition diseases which require surgeries, mainly malignant tumor
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of FloTrack system for monitoring postoperative transfusion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of parameters and weight change between pre and post operation.
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

Not applicable
Gender Male and Female
Key inclusion criteria Persons who fills everything the following
1) a person of 20years or more
2) a person who gives written informed
consent
Key exclusion criteria 1) a person with an absolute arrhythmia
2) a person who are ineligible in the opinion of the investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Terahima
Organization Hitachi, Ltd. Hitachinaka General Hospital
Division name Department of surgery
Zip code
Address 20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL 029-354-5111
Email h-tera@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Hiyama
Organization Hitachi, Ltd. Hitachinaka General Hospital
Division name Department of surgery
Zip code
Address 20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL 029-354-5111
Homepage URL
Email kazuhiro.hiyama.hb@hitachi.com

Sponsor
Institute Hitachi, Ltd. Hitachinaka General Hospital
Institute
Department

Funding Source
Organization none
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
2014 Year 08 Month 09 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 Preinitiation
Date of protocol fixation
2014 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 09 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 1) Prameters of FloTrack
2) Bowy weight of pre and post operation

Management information
Registered date
2014 Year 08 Month 09 Day
Last modified on
2014 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017217

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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