UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014905 |
|---|---|
| Receipt number | R000017327 |
| Scientific Title | The comparison between the switch oblique method and a virtual bronchoscopic navigation system. |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2017/08/30 21:44:42 |
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Basic information
Public title
The comparison between the switch oblique method and a virtual bronchoscopic navigation system.
Acronym
The comparison between the switch oblique method and a virtual bronchoscopic navigation system.
Scientific Title
The comparison between the switch oblique method and a virtual bronchoscopic navigation system.
Scientific Title:Acronym
The comparison between the switch oblique method and a virtual bronchoscopic navigation system.
Region
| Japan |
Condition
Condition
Benign or malignant pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the ability to analyse CT for bronchoscopic navigation between the switch oblique method and LungPoint, a commercially available virtual bronchoscopic navigation system.
Basic objectives2
Others
Basic objectives -Others
The comparison of CT analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of bronchi identified, and the quality of the routes proposed.
Key secondary outcomes
operate time
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The patients who underwent a bronchoscopic examination.
Key exclusion criteria
none
Target sample size
49
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
Address
2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.
TEL
06-6879-3831
tkijima@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Miyake |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
Address
2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.
TEL
06-6879-3831
Homepage URL
kotaromiyake@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka 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
| 2014 | Year | 09 | Month | 01 | 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
The switch oblique method is more precise than LungPoint.
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
| 2014 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
We collect CT images of candidate patients and analyze them by the switch oblique method and LungPoint.
Management information
Registered date
| 2014 | Year | 08 | Month | 20 | Day |
Last modified on
| 2017 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017327
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
