UMIN-CTR Clinical Trial

Basic information
Public title	The comparison between the switch oblique method and a virtual bronchoscopic navigation system.(2)
Acronym	The comparison between the switch oblique method and a virtual bronchoscopic navigation system.(2)
Scientific Title	The comparison between the switch oblique method and a virtual bronchoscopic navigation system.(2)
Scientific Title:Acronym	The comparison between the switch oblique method and a virtual bronchoscopic navigation system.(2)
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 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 number of bronchi identified, and the quality of the routes proposed.
Key secondary outcomes	operate 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	49

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	Osaka university
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Hospital
Address	2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.
Tel	06-6210-8290
Email	shiken@hp-crc.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	2017 Year 08 Month 22 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	2016 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date	2016 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Data processing

Management information
Registered date	2016 Year 08 Month 22 Day
Last modified on	2021 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027317