UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002506 |
|---|---|
| Receipt number | R000003072 |
| Scientific Title | Radiofrequency ablation for renal cell carcinoma using a switchin controller |
| Date of disclosure of the study information | 2009/09/16 |
| Last modified on | 2011/12/25 13:15:12 |
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Basic information
Public title
Radiofrequency ablation for renal cell carcinoma using a switchin controller
Acronym
RFA for renal cell carcinoma using a switchin controller
Scientific Title
Radiofrequency ablation for renal cell carcinoma using a switchin controller
Scientific Title:Acronym
RFA for renal cell carcinoma using a switchin controller
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Nephrology | Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety of radiofrequency ablation with a switching contrller used for the treatment of renal cell carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of adverse effects after radiofrequency ablation.
Key secondary outcomes
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 | Maneuver |
Interventions/Control_1
12-month enrollment. 12-month follow-up. Number of subjects: 33.
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. Patients with renal cell carcinoma diagnosed by biopsy.
2. The maximum diameter of10cm or smaller.
3. Not a surgical candidate.
4. No abnormal function in the main organs.
a) white blood count of 3000/mm3.
b) Hgb of 8.0g/dl or more.
c) Cr of 2.0 mg/dl or less.
d) SpO2 of 92% or more.
e) bil of 2.0mg/dl or less.
5. Age of 20 years or more.
6. PS of 0 or 1.
7. Life-expectancy of 2 months or longer.
8. Informed consent from the patient.
Key exclusion criteria
1. Abnormal coagulability
a) platelet count of 50000/mm3 or less.
b) INR greater than 1.5.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Yamakado |
Organization
Mie University Hospital
Division name
Department of Radiology
Zip code
Address
2-174 Edobashi, Tsu Mie, 514-8507, Japan
TEL
059-231-5029
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | koichiro Yamakado |
Organization
Mie University Hospital
Division name
Department of Radiology
Zip code
Address
TEL
Homepage URL
yama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Radiology, Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Radiology, Mie University 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
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
| 2009 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 16 | Day |
Last modified on
| 2011 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003072
