UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between altered body temperature and sensitivity to cold of the patients during renal cryoablation
Title of the study (Brief title)	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	Takao Hiraki
Organization	Okayama University Medical School
Division name	Department of Radiology
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	Eiko Hoshina
Organization	Okayama University Hospital
Division name	Center of Research and Educational for Nursing
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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