UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007699 |
|---|---|
| Receipt number | R000009052 |
| Scientific Title | Safety evaluation of cryoablation device ICS4 in cryoablation of liver tumors |
| Date of disclosure of the study information | 2012/04/09 |
| Last modified on | 2021/10/25 10:41:07 |
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Basic information
Public title
Safety evaluation of cryoablation device ICS4 in cryoablation of liver tumors
Acronym
Safety evaluation of cryoablation device ICS4
Scientific Title
Safety evaluation of cryoablation device ICS4 in cryoablation of liver tumors
Scientific Title:Acronym
Safety evaluation of cryoablation device ICS4
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety evaluation of cryoablation device ICS4
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
safety
Key secondary outcomes
efficacy
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
Cryoablation for liver tumors
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. Clinical diagnosis of liver tumor.
2. Standard treatments such as resection, TAE, RFA, or chemotherapy are not indicated.
3. Performance status 0 to 2.
4. 20 years old or older.
5. Life expectancy more than 3 months.
6. Informed consent can be obtained.
Key exclusion criteria
1. Coagulopathies.
2. Severe liver cirrhosis.
3. The diameter of a tumor is 7 cm or more, and a tumor total is seven or more.
4. There are vascular invasions or extrahepatic metastases.
5. Bleeding tendencies.
6. Uncontrolled infection.
7. Difficulties in communication.
8. Pregnant woman.
9. Excluded by the attending physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Tanabe |
Organization
School of Medicine, Keio University
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Keio University
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
| 2012 | Year | 04 | Month | 09 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | 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
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009052
