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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032196
Receipt No. R000036681
Scientific Title Verification of the effectiveness of high elastic mattress "NEO 3 D mattress" for operation table
Date of disclosure of the study information 2018/04/12
Last modified on 2018/04/11

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Basic information
Public title Verification of the effectiveness of high elastic mattress "NEO 3 D mattress" for operation table
Acronym Verification of the effectiveness of high elastic mattress "NEO 3 D mattress" for operation table
Scientific Title Verification of the effectiveness of high elastic mattress "NEO 3 D mattress" for operation table
Scientific Title:Acronym Verification of the effectiveness of high elastic mattress "NEO 3 D mattress" for operation table
Region
Japan

Condition
Condition Non obese patient
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison and verify the body pressure dispersion effect of high elasticity mattress and low friction mattress in adult patients within the normal range of BMI value and confirm that equivalent effects can be obtained.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes High resilience mattress , low repulsion mattress, supine position, measure body pressure of the head, shoulder blades and sacrum with a body pressure measuring device.
Key secondary outcomes BMI normal body weight, serum albumin , hemoglobin within the reference value in adult patients
Compare skin, neurological symptoms, presence of back pain before and after surgery.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Compare the body pressure dispersion effect of high modulus mattress and low friction mattress of adult patient within the normal range of BMI value and confirm that equivalent effect can be obtained.
Interventions/Control_2 One month from April, Heisei 30
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
30 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. BMI normal body weight, serum albumin (Alb), hemoglobin (Hb) within the reference value in adult patients
Key exclusion criteria 1. Outside BMI standard value in adult patients, outside serum albumin (Alb) and hemoglobin (Hb) standard value
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu,Teruya
Organization Kasugai Municipal Hospital
Division name Operating room
Zip code
Address 1-1-1,Takaki-cho,Kasugai-shi,Aichi
TEL 0568-57-0057
Email Hirokazu.teru@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu,Teruya
Organization Kasugai Municipal Hospital
Division name Operating room
Zip code
Address 1-1-1, Takaki-cho,Kasugai-shi,Aichi
TEL 0568-57-0057
Homepage URL
Email Hirokazu.teru@gmail.com

Sponsor
Institute Kasugai Municipal Hospital
Institute
Department

Funding Source
Organization Kasugai Municipal Hospital
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
2018 Year 04 Month 12 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
2018 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 12 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
2018 Year 04 Month 11 Day
Last modified on
2018 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036681

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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