UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019077 |
|---|---|
| Receipt number | R000022057 |
| Scientific Title | Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502) |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2020/09/14 10:38:17 |
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Basic information
Public title
Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502)
Acronym
Cryoablation for painful bone and soft tissue tumors (SCIRO-1502)
Scientific Title
Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502)
Scientific Title:Acronym
Cryoablation for painful bone and soft tissue tumors (SCIRO-1502)
Region
| Japan |
Condition
Condition
Painful bone and soft tissue tumor
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of percutaneous cryoablation for painful bone and soft tissue tumors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Number of adverse events (Time Frame: 1 month post-cryoablation)
Key secondary outcomes
Difference in VAS, efficacy, and imagings 1 month after cryoablation
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
Following percutaneously inserting electrode(IceSeed or IceRod; Galil Medical, Yokneam, Israel), cryoablation for painful bone and soft tissue tumor is performed using CryoHit (Galil Medical); cryoablation is performed in two cycles of maximum 15 minutes freezing and at least 2 minutes thawing.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Painful bone and soft tissue tumor with resistance of medication.
2) Pathologically confirmed painful bone and soft tissue tumor.
3) Target lesion is evaluated with imagings.
4) Life expectancy >= 1 month.
5) Written informed consent.
6) Patient's age is more than 20 years old.
7) Not a candidate for surgery or refuse surgery.
Key exclusion criteria
1) Vital organ and/or vessel on the needle route.
2) Patient has the following comorbidities.
a) Heart failure (NYHA >= III)
b) Active infection except for virus hepatitis
3) Body temperature of 38 degree or more.
4) Target lesion is not able to be evaluated with imagings.
5) Pregnant.
6) Worse bone fracture caused by cryoablation.
7) Worse quality of life caused by cryoablation.
8) Inadequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions.
9) Not eligible determined by the responding physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Iguchi |
Organization
Okayama University Hospital
Division name
Department of Radiology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL
+81-86-235-7315
susumu@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Iguchi |
Organization
Okayama University Hospital
Division name
Department of Radiology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL
+81-86-235-7313
Homepage URL
iguchi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dept. of Radiology, Okayama University Medical School
Address
2-5-1 Shikata-cho, Kita-ku, Okayama city
Tel
+81-86-235-6503
radiol@cc.okayama-u.ac.jp
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
| 2015 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 19 | Day |
Last modified on
| 2020 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022057
