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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015640
Receipt No. R000018179
Scientific Title Effectiveness of venous perfusion assist system for postoperative edema in patients with upper limb surgery
Date of disclosure of the study information 2014/11/08
Last modified on 2017/10/01

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Basic information
Public title Effectiveness of venous perfusion assist system for postoperative edema in patients with upper limb surgery
Acronym Effectiveness of venous perfusion assist system for postoperative edema in patients with upper limb surgery
Scientific Title Effectiveness of venous perfusion assist system for postoperative edema in patients with upper limb surgery
Scientific Title:Acronym Effectiveness of venous perfusion assist system for postoperative edema in patients with upper limb surgery
Region
Japan

Condition
Condition upper limb surgery
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clairy if venous perfusion assist system affects outcome in patients with upper limb surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Edema
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 venous perfusion assist system
Interventions/Control_2 control
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria upper limb surgery
Key exclusion criteria Bilateral
polytrauma
HD
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Yamazaki
Organization Aizawa Hospital
Division name Department of Orthopedic surgery
Zip code
Address 1-5-2 Honjo, Matsumoto, Japan 390-8510
TEL 0263-33-8600
Email hiroshiymzk1017@ybb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Yamazaki
Organization Aizawa Hospital
Division name Department of Orthopedic surgery
Zip code
Address 1-5-2 Honjo, Matsumoto, Japan 390-8510
TEL 0263-33-8600
Homepage URL
Email hiroshiymzk1017@ybb.ne.jp

Sponsor
Institute Aizawa Hospital
Institute
Department

Funding Source
Organization Aizawa hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Aizawa hospital
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 11 Month 08 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 No longer recruiting
Date of protocol fixation
2014 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 08 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
2014 Year 11 Month 08 Day
Last modified on
2017 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018179

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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