UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014571 |
|---|---|
| Receipt number | 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 10:54:51 |
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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
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
munesumi@hotmail.com
Public contact
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
munesumi@hotmail.com
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016944
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