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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name