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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033284
Receipt No. R000037791
Official scientific title of the study Multicenter prospective trial of transbronchial cryobiopsy to evaluate its safety and utility
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/06

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Basic information
Official scientific title of the study Multicenter prospective trial of transbronchial cryobiopsy to evaluate its safety and utility
Title of the study (Brief title) Multicenter prospective trial of transbronchial cryobiopsy
Region
Japan

Condition
Condition Diffuse interstitial lung disease (interstitial pneumonia, idiopathic pulmonary fibrosis, chronic hypersensitivity pneumonitis, sarcoidosis), malignant tumor (lung cancer, mesothelioma, metastatic lung carcinoma), respiratory infectious disease (tuberculosis, nontuberculosis mycobacterial infection, pulmonary aspergillosis), other diseases
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and utility of transbronchial cryobiopsy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Provability of moderate to severe adverse events
Key secondary outcomes

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 Respiraotry disease
Key exclusion criteria 1) Patients are excluded if they have past history of severe allergy to sedative drugs (lidocaine, midazolam, pethidine and so on)
2) Patients are excluded if they are suspected to have tendency of bleeding from cryobiopsy lesion because of aneurysm of bronchoartery and lung metastasis of renal cell carcinoma and so on.
3) Patients are excluded if they can't stop anticoagulation therapy.
4) Patients are excluded if they have uncontrolled comlication such as unstable angina, acute myocardial infarction, heart failure and severe bronchial asthma attack.
5) Patients are excluded if they are pregnant.
6) Patients are excluded if their doctor decide not to include.
Target sample size 110

Research contact person
Name of lead principal investigator Minoru Inomata
Organization Japanese Red Cross Medical Center
Division name Department of Pulmonary Medicine
Address 4-1-22 Hiroo Shibuya-ku Tokyo
TEL 03-3400-1311
Email inomataminoru@nms.ac.jp

Public contact
Name of contact person Minoru Inomata
Organization Japanese Red Cross Medical Center
Division name Department of Pulmonary Medicine
Address 4-1-22 Hiroo Shibuya-ku Tokyo
TEL 03-3400-1311
Homepage URL
Email inomataminoru@nms.ac.jp

Sponsor
Institute Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization Japanese Red Cross Medical Center
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 07 Month 04 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 04 Day
Anticipated trial start date
2018 Year 07 Month 04 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 To evaluate safety and utility of transbronchial cryobiopsy

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037791

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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