UMIN-CTR Clinical Trial

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
Email	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
Email	kotaromiyake@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028796