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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023559
Receipt No. R000026439
Scientific Title Relationship between altered body temperature and sensitivity to cold of the patients during renal cryoablation
Date of disclosure of the study information 2016/08/15
Last modified on 2016/06/30

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Basic information
Public title Relationship between altered body temperature and sensitivity to cold of the patients during renal cryoablation
Acronym Relationship between altered body temperature and sensitivity to cold of the patients during renal cryoablation
Scientific Title Relationship between altered body temperature and sensitivity to cold of the patients during renal cryoablation
Scientific Title:Acronym Relationship between altered body temperature and sensitivity to cold of the patients during renal cryoablation
Region
Japan

Condition
Condition kidney cancer
Classification by specialty
Radiology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The change in body temperature and cold feeling during cryotherapy of renal cell carcinoma
Basic objectives2 Others
Basic objectives -Others The correlation between change in body temperature and cold feeling
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in body temperature
Key secondary outcomes Cold feeling
Correlation between change in body temperature and cold feeling

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 To take the body temperature
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 1.The patients who receive the renal cryotherapy in our Hospital from August 1, 2016 to July 31, 2017.
2.The patients who provide written informed consent to participate this study
Key exclusion criteria 1.the patients with neurological disorder
2.the patient with dermatological disorder
3.the patient with cognitive and perception disorder
4.the patients under epidural, and lumber
anesthesia
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Hiraki
Organization Okayama University Medical School
Division name Department of Radiology
Zip code
Address 2-5-1 Kitaku Shikatacho, Okayama, Japan 700-8558
TEL 086-235-7313
Email takaoh@tc4.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiko Hoshina
Organization Okayama University Hospital
Division name Center of Research and Educational for Nursing
Zip code
Address 2-5-1 Shikata-cho Kita-ku Okayama City Okayama
TEL 086-235-6090
Homepage URL
Email ehoshina@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization applied for The Taiyo Life Welfare Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2016 Year 08 Month 15 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
2016 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 08 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
2016 Year 08 Month 09 Day
Last modified on
2016 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026439

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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