UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013732 |
|---|---|
| Receipt number | R000016033 |
| Scientific Title | The assesssment of efficacy and safety of Irreversible Electroporation (IRE) for patients with hepatocellular carcinoma (HCC) |
| Date of disclosure of the study information | 2014/04/16 |
| Last modified on | 2014/07/03 16:01:05 |
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Basic information
Public title
The assesssment of efficacy and safety of Irreversible Electroporation (IRE) for patients with hepatocellular carcinoma (HCC)
Acronym
IRE therapy for patients with HCC
Scientific Title
The assesssment of efficacy and safety of Irreversible Electroporation (IRE) for patients with hepatocellular carcinoma (HCC)
Scientific Title:Acronym
IRE therapy for patients with HCC
Region
| Japan |
Condition
Condition
Hepatocellualr carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assesse the efficacy and safety of Irreversible Electroporation (IRE) for patients with HCC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
the effect and usefulness of therapy
Key secondary outcomes
the safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Irreversible Electroporation(IRE)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Liver function: Child A, B
2. WBC>2000
3. Plt>50000
4. Cr<3.0
5. Normal ECG
6. PS: 0, 1
7. Survival time>4 weeks
8. Tumor size and number: less than or equal 3cm and 3 or less than or equal 5cm and solitary
Key exclusion criteria
1. Patients with other malignancy
2. Pregnancy case
3. Patients with severe heart brain disease
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fuminori Moriyasu |
Organization
Tokyo Medical University
Division name
Gastroenterology and Hepatology
Zip code
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
moriyasu@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsutoshi Sugimoto |
Organization
Tokyo Medical University
Division name
Gastroenterology and Hepatology
Zip code
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
Homepage URL
sugimoto@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 04 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 16 | Day |
Last modified on
| 2014 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016033
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| Registered date | File name |
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| Registered date | File name |
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