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 2021/07/16 11:59:08

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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

Email

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

36

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

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

2021 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=R000040479


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name