UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035529 |
|---|---|
| Receipt number | R000040479 |
| Scientific Title | Clinical trial of Virtual Brochoscopic Procedural Planning (VFPP) method of ZioStation2 CT bronchoscopy navigation |
| Date of disclosure of the study information | 2019/01/12 |
| Last modified on | 2024/08/15 12:37:50 |
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Basic information
Public title
Clinical trial of Virtual Brochoscopic Procedural Planning (VFPP) method of ZioStation2 CT bronchoscopy navigation
Acronym
Clinical trial of Virtual Brochoscopic Procedural Planning (VFPP) method of ZioStation2 CT bronchoscopy navigation
Scientific Title
Clinical trial of Virtual Brochoscopic Procedural Planning (VFPP) method of ZioStation2 CT bronchoscopy navigation
Scientific Title:Acronym
Clinical trial of Virtual Brochoscopic Procedural Planning (VFPP) method of ZioStation2 CT bronchoscopy navigation
Region
| Japan |
Condition
Condition
Pulmonary Peripheral Lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
ZioStation 2 CT bronchoscopy navigation is the first software which is equipped with a feature dedicated to Virtual Fluoroscopic Preprocedural Planning (VFPP) method. In this study, efficacy and safety of ZioStation 2 CT bronchoscopy navigation VFPP method is evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic yield and success rate of correcting position of EBUS-GS by VFPP method
Key secondary outcomes
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 |
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 with positive bronchus sign were recruited
Key exclusion criteria
Patients who do not have consent to this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Miyake |
Organization
Osaka University Hospital
Division name
Respiratory Medicine
Zip code
565-0871
Address
2-15, Yamadaoka, Suita, Osaka, JAPAN
TEL
06-6879-5111
kotaromiyake@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Miyake |
Organization
Osaka University Hospital
Division name
Respiratory Medicine
Zip code
565-0871
Address
2-15, Yamadaoka, Suita, Osaka, JAPAN
TEL
06-6879-5111
Homepage URL
kotaromiyake@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ziosoft, 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
IRB of Osaka University
Address
2-15, Yamadaoka, Suita, Osaka, JAPAN
Tel
06068795111
rinri@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
| 2019 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36682085/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36682085/
Number of participants that the trial has enrolled
24
Results
Results: Zio-VFPP was performed in 24 patients, and EBUS findings improved in nine patients. Before Zio-VFPP, 18 patients were "outside," but after Zio-VFPP, the number decreased to ten. Statistically, this difference was significant (p = 0.0392). There were no cases in which EBUS findings worsened with Zio-VFPP.
Results date posted
| 2024 | Year | 08 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-six patients who had pulmonary lesions with long axes <= 20 mm and who underwent thin-slice CT with <= 0.625-mm thickness were enrolled.
Participant flow
We initiated bronchoscopy using EBUS with a guide sheath (EBUS-GS) while referring to Ziostation2 bronchoscopic navigation. When the probe was not "within" a lesion, we attempted to correct its position based on Zio-VFPP. EBUS findings before and after Zio-VFPP were compared.
Adverse events
Not observed.
Outcome measures
Zio-VFPP was performed in 24 patients, and EBUS findings improved in nine patients. Before Zio-VFPP, 18 patients were "outside," but after Zio-VFPP, the number decreased to ten. Statistically, this difference was significant (p = 0.0392). There were no cases in which EBUS findings worsened with Zio-VFPP.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 12 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040479
