UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045522 |
|---|---|
| Receipt number | R000051972 |
| Scientific Title | A single center prospective interventional study for the evaluation of super-selective bronchial artery coil embolization on exercise tolerability in patients with chronic hemoptysis |
| Date of disclosure of the study information | 2021/09/20 |
| Last modified on | 2022/03/22 10:23:34 |
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Basic information
Public title
A single center prospective interventional study for the evaluation of super-selective bronchial artery coil embolization on exercise tolerability in patients with chronic hemoptysis
Acronym
Exercise tolerability study of ssBACE
Scientific Title
A single center prospective interventional study for the evaluation of super-selective bronchial artery coil embolization on exercise tolerability in patients with chronic hemoptysis
Scientific Title:Acronym
Exercise tolerability study of ssBACE
Region
| Japan |
Condition
Condition
Chronic hemoptysis
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether elective de-novo ssBACE improve 6-min walk test at one-month after the ssBACE in patients with chronic hemoptysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in 6-min walk test (m) at one-month after the ssBACE as compared to the baseline value
Key secondary outcomes
Changes in the followings as compared to the baseline values
- ABG findings -
Post-procedural PO2, PCO2, HCO3-, A-aDO2, and pH
- Spirometry findings -
%VC and FEV1.0% at 1-month after ssBACE
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
De-novo elective ssBACE
Six-min walk test
(Preprocedural and at one-month)
Arterial blood gas
(Pre- and post-procedural)
Spirometry
(Preprocedural and at one-month)
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
1. Chronic hemoptysis
2. Expected to undergo de-novo elective ssBACE
3. Written informed consent from the patient
Key exclusion criteria
1. Need for oxygenation during ssBACE
2. Difficulty to understand the study such as due to psychiatric disorder or dementia
3. Other reasons (at the attending physician's discretion)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Ishikawa |
Organization
Eishinkai Kishiwada Rehabilitation Hospital
Division name
Hemoptysis and Pulmonary-Circulation Center
Zip code
596-0827
Address
Kanmatsu-cho 2-8-10, Kishiwada City, Osaka, Japan
TEL
072-426-7777
h_ishikawa@eishinkaihsp.or.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Hara |
Organization
The Japan Society of Clinical Research
Division name
Department of Clinical Investigation
Zip code
530-0001
Address
Kita-ku Umeda 1-11-4-1000 Osaka Ekimae 4th Bldg 10F
TEL
06-6131-5495
Homepage URL
hara@japanscr.org
Sponsor or person
Institute
Hemoptysis and Pulmonary-Circulation Center
Eishinkai Kishiwada Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Hemoptysis and Pulmonary-Circulation Center
Eishinkai Kishiwada Rehabilitation Hospital
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
IRB of Eishinkai Kishiwada Rehabilitation Hospital
Address
Kanmatsu-cho 2-8-10, Kishiwada City, Osaka, Japan
Tel
072-426-7777
h@ishikawa.email.ne.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
| 2021 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
113
Results
Results are expected to be published elsewhere (now under review).
Results date posted
| 2021 | Year | 09 | Month | 20 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Manuscript under review
Date of the first journal publication of results
Baseline Characteristics
Results are expected to be published elsewhere (now under review).
Participant flow
Results are expected to be published elsewhere (now under review).
Adverse events
Results are expected to be published elsewhere (now under review).
Outcome measures
Results are expected to be published elsewhere (now under review).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 04 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 08 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051972
| Research Plan | |
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| 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 |
