UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004870 |
|---|---|
| Receipt number | R000003688 |
| Scientific Title | Research of safety and efficacy of percutaneous vertebroplasty for fragile bone lesions due to metastatic bone tumor or osteoporosis |
| Date of disclosure of the study information | 2011/01/13 |
| Last modified on | 2014/01/13 19:31:30 |
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Basic information
Public title
Research of safety and efficacy of percutaneous vertebroplasty for fragile bone lesions due to metastatic bone tumor or osteoporosis
Acronym
Research of safety and efficacy of percutaneous vertebroplasty
Scientific Title
Research of safety and efficacy of percutaneous vertebroplasty for fragile bone lesions due to metastatic bone tumor or osteoporosis
Scientific Title:Acronym
Research of safety and efficacy of percutaneous vertebroplasty
Region
| Japan |
Condition
Condition
Patients who are suitable for this therapy if some conditions are right.
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To research the safety and efficacy of percutaneous vertebroplasty for fragile bone lesions due to metastatic bone tumor or osteoporosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
To estimate the occurence rate of adverse effects of vertebroplasty.
Key secondary outcomes
To estimate the pain relief rate and the reduction rate of pain medicine use.
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
| Maneuver |
Interventions/Control_1
percutaneous vertebroplasty
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with vertebral lesions due to metastatic bone tumor or osteoporosis
Key exclusion criteria
Patients with acute infection, hemorrhagic tendency, severe cardiopulmonary disorder, severe obesity, hypovolemic state, or the presumable occurence of adverse effects.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki NOGUCHI |
Organization
Saga University
Division name
Dept of Radioloogy
Zip code
Address
Saga City
TEL
0952-34-2309
tnogucci@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Noguchi |
Organization
Saga University
Division name
Dept of Radiology
Zip code
Address
5-1-1, Nabeshima, Saga City, Saga Province, JAPAN
TEL
0952-34-2309
Homepage URL
tonoguti@cc.saga-u.ac.jp
Sponsor or person
Institute
Dept of Radiology, Saga University
Institute
Department
Personal name
Funding Source
Organization
Dept of Radiology, Saga 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
| 2011 | Year | 01 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | 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
| 2011 | Year | 01 | Month | 13 | Day |
Last modified on
| 2014 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003688
