UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025023 |
|---|---|
| Receipt number | R000028796 |
| Scientific Title | The comparison between the direct oblique method and virtual bronchoscopic navigation systems. |
| Date of disclosure of the study information | 2016/11/28 |
| Last modified on | 2021/12/04 16:33:45 |
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Basic information
Public title
The comparison between the direct oblique method and virtual bronchoscopic navigation systems.
Acronym
The comparison between the direct oblique method and virtual bronchoscopic navigation systems.
Scientific Title
The comparison between the direct oblique method and virtual bronchoscopic navigation systems.
Scientific Title:Acronym
The comparison between the direct oblique method and virtual bronchoscopic navigation systems.
Region
| Japan |
Condition
Condition
Pulmonary peripheral lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the ability to analyse CT for bronchoscopic navigation between the direct oblique method and commercially available virtual bronchoscopic navigation systems.
Basic objectives2
Others
Basic objectives -Others
The comparison of CT analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The location of terminals of the calculated routes
Key secondary outcomes
The comparison ob bronchoscopic simulation to the identical terminals, the airway identification performance and procedure time
Base
Study type
Others,meta-analysis etc
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
47
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
565-0871
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 | Kotaro |
| Middle name | |
| Last name | Miyake |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
565-0871
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
Clinical Trial Center, Osaka University
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8290
acr-jim@dmi.med.osaka-u.ac.jp
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
| 2016 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/29901530/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29901530/
Number of participants that the trial has enrolled
47
Results
https://pubmed.ncbi.nlm.nih.gov/29901530/
Results date posted
| 2021 | Year | 12 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/29901530/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/29901530/
Adverse events
N/A
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/29901530/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a simulation study using CT images which were obtained previously.
Management information
Registered date
| 2016 | Year | 11 | Month | 28 | Day |
Last modified on
| 2021 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028796
