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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002504
Receipt No. 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

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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
Email

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
Email yama@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Radiology, Mie University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003070

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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