UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021203 |
|---|---|
| Receipt number | R000024177 |
| Scientific Title | NAVIGATE: Clinical Evaluation of superDimension Navigation System for Electromagnetic Navigation Bronchoscopy |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2017/06/01 17:37:10 |
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Basic information
Public title
NAVIGATE: Clinical Evaluation of superDimension Navigation System for Electromagnetic Navigation Bronchoscopy
Acronym
NAVIGATE: Clinical Evaluation of superDimension Navigation System for Electromagnetic Navigation Bronchoscopy
Scientific Title
NAVIGATE: Clinical Evaluation of superDimension Navigation System for Electromagnetic Navigation Bronchoscopy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hideo Saka |
Organization
Nagoya Medical Center
Division name
Department of medical Oncology
Zip code
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL
052-951-1111
saka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Kato |
Organization
Covidien Japan Inc.
Division name
Medical Affairs
Zip code
Address
4-10-2, Yoga, Setagaya-ku, Tokyo, Japan
TEL
03-5717-1700
Homepage URL
hiroaki.kato@medtronic.com
Sponsor or person
Institute
Covidien Japan Inc.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024177
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
