UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	NAVIGATE: Clinical Evaluation of superDimension Navigation System for Electromagnetic Navigation Bronchoscopy
Title of the study (Brief title)	NAVIGATE: Clinical Evaluation of superDimension Navigation System for Electromagnetic Navigation Bronchoscopy
Region	Japan

Condition
Condition	Lung Lesion(s) Requiring Evaluation
Classification by specialty	Pneumology Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy(ENB) procedures using the superDimension navigation system.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of pneumothorax related to the index procedure rated as Grade 2 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE) scale.
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Subject presents with lung lesion(s) requiring evaluation 2.Subject is willing and able to provide informed consent to participate in the study 3.Subject is candidate for elective ENBprocedure 4.Subject is over the age of 20
Key exclusion criteria	1.The subject is unable or unwilling to comply with study follow-up schedule 2.The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study 3.Female subjects who are pregnant or nursing as determined by standard site practices
Target sample size	180

Research contact person
Name of lead principal investigator	Hideo Saka
Organization	Nagoya Medical Center
Division name	Department of medical Oncology
Address	4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL	052-951-1111
Email	saka@med.nagoya-u.ac.jp

Public contact
Name of contact person	Hiroaki Kato
Organization	Covidien Japan Inc.
Division name	Medical Affairs
Address	4-10-2, Yoga, Setagaya-ku, Tokyo, Japan
TEL	03-5717-1700
Homepage URL
Email	hiroaki.kato@medtronic.com

Sponsor
Institute	Covidien Japan Inc.
Institute
Department

Funding Source
Organization	Covidien Japan Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT02410837
Org. issuing International ID_1	ClinicalTraials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科大学（東京都） 日本医科大学（東京都） 国立がん研究センター中央病院（東京都） 聖マリアンナ医科大学（神奈川県） 名古屋医療センター（愛知県） 京都大学（京都府）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 25 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Evaluate outcomes following electromagnetic navigation bronchoscopy (ENB) procedures using the superDimensionnavigation system.

Management information
Registered date	2016 Year 02 Month 25 Day
Last modified on	2017 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024177