UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034172 |
|---|---|
| Receipt number | 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 | 2021/11/14 09:51:35 |
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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 | Hideo |
| Middle name | |
| Last name | Ishikawa |
Organization
Kishiwada Rehabilitation Hospital
Division name
Hemoptysis and Pulmonary-Circulation Center
Zip code
596-0827
Address
Kamimatsucho 2-8-10, Kishiwada city, Osaka
TEL
072-426-7777
h_ishikawa@eishinkaihsp.or.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Ishikawa |
Organization
Eishinkai Kishiwada Rehabilitation Hospital
Division name
Hemoptysis and Pulmonary-Circulation Center
Zip code
5960827
Address
Kamimatsucho 2-8-10, Kishiwada city, Osaka
TEL
072-426-7777
Homepage URL
https://www.eishinkai.hospital/
h_ishikawa@eishinkaihsp.or.jp
Sponsor or person
Institute
Eishinkai Kishiwada Rehabilitation Hospital
Institute
Department
Personal name
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
Eishinkai KIshiwada Rehabilitaiton Hp IRB
Address
Kamimatsucho 2-8-10, Kishiwada city, Osaka
Tel
072-426-7777
s_tanaka@eishinkaihsp.or.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
えいしん会 岸和田リハビリテーション病院
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
| 2018 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038953
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
