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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014571
Receipt No. R000016944
Scientific Title Bronchoscopy for Pulmonary Peripheral Lesions with Virtual Fluoroscopic Preprocedural Planning (VFPP) Combinated with EBUS-GS: A pilot study
Date of disclosure of the study information 2014/07/16
Last modified on 2014/07/16

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Basic information
Public title Bronchoscopy for Pulmonary Peripheral Lesions with Virtual Fluoroscopic Preprocedural Planning (VFPP) Combinated with EBUS-GS: A pilot study
Acronym Bronchoscopy for Pulmonary Peripheral Lesions with Virtual Fluoroscopic Preprocedural Planning (VFPP) Combinated with EBUS-GS: A pilot study
Scientific Title Bronchoscopy for Pulmonary Peripheral Lesions with Virtual Fluoroscopic Preprocedural Planning (VFPP) Combinated with EBUS-GS: A pilot study
Scientific Title:Acronym Bronchoscopy for Pulmonary Peripheral Lesions with Virtual Fluoroscopic Preprocedural Planning (VFPP) Combinated with EBUS-GS: A pilot study
Region
Japan

Condition
Condition Pulmonary Peripheral Lesions
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 we applied Virtual Fluoroscopic Preprocedural Planning (VFPP) to bronchoscopic procedure as a new navigation system. VFPP stands for the navigation system in which the trace lines between the trachea and the target lesions were constructed along the responsible bronchus on Ray Summation image similar to fluoroscopy. The trace line shown in 3D image of the lung is used as a reference for selecting the responsible bronchus during the forceps handling. VFPP is easy to prepare by power volume data from MDCT and workstation. We report the feasibility of VFPP on bronchoscopy, that has never been tried before.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnostic rate
Key secondary outcomes Lesion visualization rate, examination time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Bronchoscopy with EBUS-GS was performed by simultaneous display of VFPP
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 The patients with the peripheral lung lesions less than 30mm in longer axis were recruited at the National Hospital Organization Disaster Medical Center
Key exclusion criteria Lesions of pure ground glass opacity
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Munehisa Fukusumi
Organization National Hospital Organization Disaster Medical Center, Japan
Division name Department of Pulmonology
Zip code
Address 3256 Midori-cho Tachikawa city
TEL 042-526-5511
Email munesumi@hotmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Munehisa Fukusumi
Organization National Hospital Organization Disaster Medical Center, Japan
Division name Department of Pulmonology
Zip code
Address 3256 Midori-cho Tachikawa city
TEL 042-526-5511
Homepage URL
Email munesumi@hotmail.com

Sponsor
Institute National Hospital Organization Disaster Medical Center, Japan
Institute
Department

Funding Source
Organization Research fund of Department of Pulmonology, National Hospital Organization Disaster Medical Center, Japan
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
Address
Tel
Email

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
2014 Year 07 Month 16 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 Completed
Date of protocol fixation
2013 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 16 Day
Last modified on
2014 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016944

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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