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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033626
Receipt No. R000038327
Official scientific title of the study Examination of histological diagnosis by ultra-thin bronchoscopic findings
Date of disclosure of the study information 2018/08/03
Last modified on 2018/08/06

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Basic information
Official scientific title of the study Examination of histological diagnosis by ultra-thin bronchoscopic findings
Title of the study (Brief title) observation of XP260F
Region
Japan

Condition
Condition peripheral pulmonary lesion
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To observe the endobronchial findings of the peripheral pulmonary lesions using a ultra-thin bronchoscope.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes endobronchial findings
Key secondary outcomes The relationship between the findings and the histopathological diagnosis of the peripheral pulmonary lesion, the bronchoscope advanced at generation of bronchial branching, assessment of usefulness of physiological saline injection(intra-observer agreement, inter-observer agreement)

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)Patiants need to undergo diagnostic bronchoscopy
2) A case in which the bronchus(internal diamater less than 4mm) is reaching in to the lesion on HR-CT.
3) 20 years old or more
4)informed concent
Key exclusion criteria clinical difficulties in the trial
Target sample size 40

Research contact person
Name of lead principal investigator Mika Nakao
Organization Shimane University Faculty of Medicine
Division name Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2580
Email mika14@med.shimane-u.ac.jp

Public contact
Name of contact person Mika Nakao
Organization Shimane University Faculty of Medicine
Division name Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Address 89-1 Enya-cho, Izumo, Shimane
TEL 0853-20-2580
Homepage URL
Email mika14@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Institute
Department

Funding Source
Organization Shimane University Faculty of Medicine
Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 08 Month 03 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 09 Day
Anticipated trial start date
2018 Year 05 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information non

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038327

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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