UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012194 |
|---|---|
| Receipt number | R000014049 |
| Scientific Title | Safety cofirmatory study for Percutaneous cryoablation of vascular malformations |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2015/11/02 13:35:17 |
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Basic information
Public title
Safety cofirmatory study for Percutaneous cryoablation of vascular malformations
Acronym
SCIRO-1303 study
Scientific Title
Safety cofirmatory study for Percutaneous cryoablation of vascular malformations
Scientific Title:Acronym
SCIRO-1303 study
Region
| Japan |
Condition
Condition
vascular malformation
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety for the cryoablation of vascular malformations.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse Events
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
Percutaneous cryoablation
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Written informed consent is obtained by patient or parents.
2)Survival more than three months from a registration day can be expected.
3)Diagnosed as vascular malformation clinically(Characteristic image findings, US: hypoecho, MRI T2WI: high signal, phlebolith, skin color change, soft mass and so on)
4)Symptom (pain, swelling) thought to be due to vascular malformation is present. Or the lesion is progressive even if asymptomatic.
5) The lesion is apart from a vital organ or an important structure.
6) Operation is out of adaption or patient does not hope operation.
7) Medical treatment would not effect sufficiency.
8) Main organ function is kept.
a. White blood-cell count >2,500/mm3
b. Platelet count >50,000/mm3
c. Hemoglobin >7.0g/mm3
d. Creatinin <2.0mg/dl
e. Total bilirubin <3.0mg/dl
Key exclusion criteria
1) Under 13 years old.
2) Patients have severe comorbidities as follows:
a. Uncontroled malignant tumor.
b. Serious lung disease.
c. Serious heart trouble.
d. Serious liver disease.
e. Severe active inflammation and infectious disease.
f. Poor control diabetes.
g. Immunocompromised state including the whole steroid therapy.
h. Case having complications considered to disturb completion of the cryoablation.
4) Past history of radiation exposure to the lesion.
5) Probe insertion can't be performed safely.
6) Clinical clear bleeding tendency (PT-INR >=1.5)
7) Drugs such as antiplatelet agent, anticoagulant, thrombolytic agent can't be ceased temporarily.
8) Being pregnant or may be pregnant.
9) Considered unsuitable for being enrolled in this clinical trial by a attending physician.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Kanazawa |
Organization
Okayama University Hospital
Division name
Department of Radiology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
+81-86-235-7313
susumu@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Fujiwara |
Organization
Okayama University Hospital
Division name
Department of Radiology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
+81-86-235-7313
Homepage URL
hirofujiwar@gmail.com
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science
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
| 2013 | Year | 11 | Month | 01 | 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
| 2013 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | 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
| 2013 | Year | 11 | Month | 01 | Day |
Last modified on
| 2015 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014049
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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