UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031309
Receipt number 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 2023/02/21 17:35:09

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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 or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



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

2022 Year 12 Month 31 Day

Date of closure to data entry

2023 Year 12 Month 31 Day

Date trial data considered complete

2025 Year 12 Month 31 Day

Date analysis concluded

2025 Year 12 Month 31 Day


Other

Other related information

No data


Management information

Registered date

2018 Year 02 Month 14 Day

Last modified on

2023 Year 02 Month 21 Day



Link to view the page

Value
https://center6.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