UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008592 |
|---|---|
| Receipt number | R000010094 |
| Scientific Title | Randomized trial of transbronchial diagnosis using navigation by virtual bronchoscopy and endobronchial ultrasonography and guide sheath (EBUS-GS) with or without X-ray fluoroscopy for small pulmonary peripheral lesions |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2018/02/05 09:50:07 |
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Basic information
Public title
Randomized trial of transbronchial diagnosis using navigation by virtual bronchoscopy and endobronchial ultrasonography and guide sheath (EBUS-GS) with or without X-ray fluoroscopy for small pulmonary peripheral lesions
Acronym
Randomized trial of transbronchial diagnosis using Bf-NAVI and EBUS-GS with or without X-ray fluoroscopy for small pulmonary peripheral lesions
Scientific Title
Randomized trial of transbronchial diagnosis using navigation by virtual bronchoscopy and endobronchial ultrasonography and guide sheath (EBUS-GS) with or without X-ray fluoroscopy for small pulmonary peripheral lesions
Scientific Title:Acronym
Randomized trial of transbronchial diagnosis using Bf-NAVI and EBUS-GS with or without X-ray fluoroscopy for small pulmonary peripheral lesions
Region
| Japan |
Condition
Condition
peripheral pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To show that transbronchial diagnosis using Bf-NAVI and EBUS-GS without X-ray for pulmonary peripheral lesions is similar to the bronchoscopy with X-ray
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Yield (Diagnostic rate)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
without X-ray fluoroscopy
Interventions/Control_2
with X-ray fluoroscopy
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.small peripheral pulmonary lesions of less than 30 mm , but not determined, as lung cancer
2.Not visible by bronchoscopy
3.20 or more than 20 years of age
4.SpO2 90% or more than 90%
5.Written informed consent
Key exclusion criteria
1.Visible by bronchoscopy
2.GGO
3.Lesions deemed as benign diseases on chest CT
4.Severe complication
5.Disability of cessation of anticoagulant or antiplatelet more than 2 days
6.Pregnancy
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Tachihara |
Organization
Kobe University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL
078-382-5660
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoko Tachihara |
Organization
Kobe University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL
078-382-5660
Homepage URL
mt0318@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | 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
| 2012 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010094
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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