UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015444 |
|---|---|
| Receipt number | R000016346 |
| Scientific Title | Endobronchial lung biopsy with an ultrathin bronchoscope using Switch Oblique Method (SOM) for the diagnosis of peripheral pulmonary lesions |
| Date of disclosure of the study information | 2014/10/16 |
| Last modified on | 2016/07/31 15:07:55 |
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Basic information
Public title
Endobronchial lung biopsy with an ultrathin bronchoscope using Switch Oblique Method (SOM) for the diagnosis of peripheral pulmonary lesions
Acronym
Endobronchial lung biopsy with an ultrathin bronchoscope using Switch Oblique Method (SOM) for the diagnosis of peripheral pulmonary lesions
Scientific Title
Endobronchial lung biopsy with an ultrathin bronchoscope using Switch Oblique Method (SOM) for the diagnosis of peripheral pulmonary lesions
Scientific Title:Acronym
Endobronchial lung biopsy with an ultrathin bronchoscope using Switch Oblique Method (SOM) for the diagnosis of peripheral pulmonary lesions
Region
| Japan |
Condition
Condition
peripheral lung leisions doubting a malignancy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic yield and safety of ultrathin bronchoscope using Switch Oblique Method (SOM) in peripheral pulmonary lesions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
the accuracy of Switch Oblique Method as navigation system
Key secondary outcomes
the diagnostic yield and safety of ultrathin bronchoscope using Switch Oblique Method (SOM). complications of bronchoscopy. inspection time
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
bronchoscopy with switch oblique method
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Small peripheral pulmonary lesions of 10 mm or more and 20 mm or less deemed, but not determined, as lung cancer
2.Not visible by bronchoscopy
3.The case which is due to perform an additional positive inspection and medical treatment when diagnosis does not stick by bronchoscope inspection
4.Written informed consent
Key exclusion criteria
1.Visible by bronchoscopy
2.Lesions deemed as benign diseases on chest CT
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Imamura |
Organization
osaka medical center for cancer and cardiovascular diseases
Division name
Department of Thoracic Oncology
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, osaka,537-8511
TEL
06-6972-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takako Inoue |
Organization
osaka medical center for cancer and cardiovascular diseases
Division name
Department of Thoracic Oncology
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, osaka,537-8511
TEL
06-6972-1181
Homepage URL
okuyama-ta@mc.pref.osaka.jp
Sponsor or person
Institute
osaka medical center for cancer and cardiovascular diseases
Institute
Department
Personal name
Funding Source
Organization
osaka medical center for cancer and cardiovascular diseases
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University Hospital
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
大阪府立成人病センター(大阪府)、大阪大学大学院医学部附属病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 16 | Day |
Last modified on
| 2016 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016346
