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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031309
Receipt No. R000035739
Scientific Title Prospective observational study on short-term and long-term effects of elective performed bronchial artery embolization using gelatin sponge for recurrent hemoptysis or chronic sustained hemosputum
Date of disclosure of the study information 2018/02/15
Last modified on 2020/02/18

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Basic information
Public title Prospective observational study on short-term and long-term effects of elective performed bronchial artery embolization using gelatin sponge for recurrent hemoptysis or chronic sustained hemosputum
Acronym The effects of elective performed bronchial artery embolization for recurrent hemoptysis or chronic sustained hemosputum
Scientific Title Prospective observational study on short-term and long-term effects of elective performed bronchial artery embolization using gelatin sponge for recurrent hemoptysis or chronic sustained hemosputum
Scientific Title:Acronym The effects of elective performed bronchial artery embolization for recurrent hemoptysis or chronic sustained hemosputum
Region
Japan

Condition
Condition recurrent hemoptysis or chronic sustained hemosputum
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We conducted prospective observational study under the hypothesis that elective ssBAE using gelatin sponge may lead to attribute to the
improvement of the hemostasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Short-term and long-term effects of elective
performed bronchial artery embolization
Total hemostasis rate was observed.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria We enrolled the patients who referred to our hospital due to hemoptysis or chronic hemosputum and treated with the elective super selective bronchial artery embolization(ssBAE) using gelatin sponge.
Key exclusion criteria 1) respiratory arrest
2) hemodynamic instability
(hypotension, shock vital, myocardial ischemia or life-threatening arrhythmia)
3)severe respiratory failure patients: Under the mechanical support ventilation, PaO2/FiO2 was lower than 100.
4)severe renal dysfunction or hemodialysis patients
5)delirious state or uncooperative patients
6)can not be maintain the supine position
7)aortic dissection or aortic aneurysm or anatomical abnormality
8)risk of aspiration
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Suzuki
Organization National Center for Global Health and Medicine
Division name Department of Respiratory Medicine
Zip code 162-8655
Address Toyama
TEL 0332027181
Email manabu@nms.ac.jp

Public contact
Name of contact person
1st name Manabu
Middle name
Last name Suzuki
Organization National Center for Global Health
Division name Department of Respiratory Medicine
Zip code 162-8655
Address Toyama
TEL 0332027181
Homepage URL
Email manabu@nms.ac.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Center for Global Health and Medicine
Address 1-21-1 Toyama Shinjuku-ku, Tokyo 162-8655, Japan
Tel 0332027181
Email manabu@nms.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
2018 Year 02 Month 15 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
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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 15 Day
Date of IRB
2017 Year 09 Month 08 Day
Anticipated trial start date
2017 Year 09 Month 15 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 12 Month 31 Day
Date trial data considered complete
2023 Year 12 Month 31 Day
Date analysis concluded
2024 Year 12 Month 31 Day

Other
Other related information No data

Management information
Registered date
2018 Year 02 Month 14 Day
Last modified on
2020 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035739

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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