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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009732
Receipt No. R000011409
Scientific Title Efficacy of guide sheath suction (catheter suction) method in bronchoscopy
Date of disclosure of the study information 2013/01/09
Last modified on 2013/07/09

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Basic information
Public title Efficacy of guide sheath suction (catheter suction) method in bronchoscopy
Acronym Guide sheath suction method
Scientific Title Efficacy of guide sheath suction (catheter suction) method in bronchoscopy
Scientific Title:Acronym Guide sheath suction method
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficasy and safety of bronchoscopic guide sheath suction (catheter suction) method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic yields of bronchoscopy
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 guide sheath suction
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. Suspicous case of peripheral lung cancer (not directly bronchoscopical visible)
2. Lesion diameter >= 20 mm.
3. Age >= 20 yo.
4. SpO2 >= 90% in r.a.
5. With written informed consent
Key exclusion criteria 1. Allergy to lidocaine
2. Severe comorbidity
3. Unstable angina, severe hypertension, poor controlled asthma, recent myocardial infarction, severe infection
4. Patient with anticoagulant or antiplatelet which cannot be terminated
5. Pregnant woman
6. Unsuitable patient decided by physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Ishida
Organization Fukushima Medical University
Division name Dept Pulmonary Medicine/ Clinical Oncology Center
Zip code
Address Hikarigaoka 1, Fukushima city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Fukushima Medical University
Division name Dept Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
Email tishida@fmu.ac.jp

Sponsor
Institute Department of Pulmonary Medicine
Institute
Department

Funding Source
Organization Department of Pulmonary Medicine, Fukushima Medical University
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 01 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 07 Month 01 Day
Date of closure to data entry
2013 Year 07 Month 08 Day
Date trial data considered complete
2013 Year 07 Month 09 Day
Date analysis concluded
2013 Year 07 Month 09 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 09 Day
Last modified on
2013 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011409

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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