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 | 2025/02/27 16:37:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Objective indicators: 1) Examine the safety of treatment and complications.
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
80
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
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
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
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
Currently accepting cases
Results date posted
| 2024 | Year | 08 | Month | 21 | Day |
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
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 12 | Month | 31 | Day |
Other
Other related information
No data
Management information
Registered date
| 2018 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035739
