UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023559 |
|---|---|
| Receipt number | 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 21:48:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ehoshina@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026439
