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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034172
Receipt No. R000038953
Scientific Title Impact of super-selective bronchial artery coil embolisation using hydrogel-polymer-coated platinum coils on reduction of recanalization events in patients with hemoptysis
Date of disclosure of the study information 2018/09/16
Last modified on 2018/09/16

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Basic information
Public title Impact of super-selective bronchial artery coil embolisation using hydrogel-polymer-coated platinum coils on reduction of recanalization events in patients with hemoptysis
Acronym Impact of hydrogel-coated coil during ssBACE
Scientific Title Impact of super-selective bronchial artery coil embolisation using hydrogel-polymer-coated platinum coils on reduction of recanalization events in patients with hemoptysis
Scientific Title:Acronym Impact of hydrogel-coated coil during ssBACE
Region
Japan

Condition
Condition Patients with hemoptysis who undergo ssBACE
Classification by specialty
Pneumology Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the impact of super-selective bronchial artery coil embolisation using hydrogel-polymer-coated platinum coils on reduction of recanalization events in patients with hemoptysis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recanalization rates of embolized-hemoptysis-related arteries evaluated by enhanced CT angiography 6 months after ssBACE
Key secondary outcomes 1. Recanalization rates of embolized-hemoptysis-related arteries evaluated by cine-angiography in patients with recurrent hemoptysis at next series ssBACE
2. Cumulative incidence of recurrent hemoptysis

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
100 years-old >
Gender Male and Female
Key inclusion criteria Meet all of the following criteria
1. adult
2. patients with hemoptysis who are planning to undergo ssBACE
3. can understand the study, make a decision by themselves
Key exclusion criteria Meet one of the following criteria
1. Participation in other clinical studies within 3 months before the enrollment.
2. those who cannot understand the study such as due to psychiatric disorders, etc.
3. other inappropriate candidates decided by attending physicians
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Ishikawa
Organization Kishiwada Rehabilitation Hospital
Division name Hemoptysis and Pulmonary-Circulation Center
Zip code
Address Uematsucho 2-8-10, Kishiwada city, Osaka
TEL 072-426-7777
Email h_ishikawa@eishinkaihsp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Ishikawa
Organization Kishiwada Rehabilitation Hospital
Division name Hemoptysis and Pulmonary-Circulation Center
Zip code
Address Uematsucho 2-8-10, Kishiwada city, Osaka
TEL 072-426-7777
Homepage URL https://www.eishinkai.hospital/
Email h_ishikawa@eishinkaihsp.or.jp

Sponsor
Institute Kishiwada Rehabilitation Hospital
Institute
Department

Funding Source
Organization TERUMO Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 09 Month 16 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 10 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2018 Year 09 Month 16 Day
Last modified on
2018 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038953

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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