UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003293
Receipt number R000003986
Scientific Title Usefulness of three-dimensional ultrasonography in percutaneous radiofrequency ablation.
Date of disclosure of the study information 2010/03/05
Last modified on 2010/03/05 20:13:45

* 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

Usefulness of three-dimensional ultrasonography in percutaneous radiofrequency ablation.

Acronym

Three-dimensional ultrasonography in percutaneous radiofrequency ablation.

Scientific Title

Usefulness of three-dimensional ultrasonography in percutaneous radiofrequency ablation.

Scientific Title:Acronym

Three-dimensional ultrasonography in percutaneous radiofrequency ablation.

Region

Japan


Condition

Condition

Liver neoplasm

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the usefulness of three-dimensional ultrasonography in performing percutaneous radiofrequency ablation therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. Safety.
2. The ability of visualizing the position of the electrodes.

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

Interventions/Control_1

Three-dimensional ultrasonography

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with liver neoplasm.

Key exclusion criteria

Patients who do not agree the purpose and procedure of the study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Imamura

Organization

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Division name

Division of Hepatology, Department of Internal Medicine

Zip code


Address

18-22,Honkomagome 3chome, Bunkyo-ku, Tokyo 113-8677, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Jun Imamura

Organization

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Division name

Division of Hepatology, Department of Internal Medicine

Zip code


Address

18-22,Honkomagome 3chome, Bunkyo-ku, Tokyo 113-8677, Japan

TEL

03-3823-2101

Homepage URL


Email

jun.imamu@gmail.com


Sponsor or person

Institute

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

がん・感染症センター都立駒込病院(東京都)


Other administrative information

Date of disclosure of the study information

2010 Year 03 Month 05 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

Open public recruiting

Date of protocol fixation

2010 Year 03 Month 05 Day

Date of IRB


Anticipated trial start date

2010 Year 03 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

2010 Year 03 Month 05 Day

Last modified on

2010 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name