UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002504 |
|---|---|
| Receipt number | R000003070 |
| Scientific Title | Radiofrequency ablation using a switching controller for lung neopasms |
| Date of disclosure of the study information | 2009/09/16 |
| Last modified on | 2012/12/28 15:14:19 |
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Basic information
Public title
Radiofrequency ablation using a switching controller for lung neopasms
Acronym
RFA using a switching controller for lung neopasms
Scientific Title
Radiofrequency ablation using a switching controller for lung neopasms
Scientific Title:Acronym
RFA using a switching controller for lung neopasms
Region
| Japan |
Condition
Condition
Malignant lung neoplasms
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Complication after lung radiofrequency.
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
12-month enrollment, 12-month follow-up.
Number of subjects: 33.
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. Patients with malignant lung neoplasms diagnosed by biopsy or radiographic findings (CT or PET-C).
2. The maximum tumor size of 2-5cm with a tumor number of 3 or less.
3. SpO2 of 92% or more.
4. Not a surgical candidate.
5. No abnormality in major organs.
a) white blood count of 3000/mm3 or more.
b) Hgb of 8.0g/dl.
c) Cr of 2.0mg/dl or less.
d) bil of 2.0mg/dl or less.
6. Age of 20 years or more.
7. PS of 0 or 1.
8. Life expectancy of 2 months or more.
9. Informed consent from the patient.
Key exclusion criteria
1. Abnormal coagulability.
a) platelet count of 50000 or less.
b) INR of less than 1.5.
2. Previous radiotherapy.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Yamakado |
Organization
Mie University Hospital
Division name
Interventional Radiology
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-231-5029
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Yamakado |
Organization
Mie University Hospital
Division name
Interventional Radiology
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-231-5029
Homepage URL
yama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Radiology, Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Radiology, Mie University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2009 | Year | 09 | 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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 09 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 16 | Day |
Last modified on
| 2012 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003070
