UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061747 |
|---|---|
| Receipt number | R000070601 |
| Scientific Title | A Prospective Cohort Study on the Diagnosis and Therapeutic Interventions for Adult Airway Foreign Body Cases |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/30 21:44:06 |
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Basic information
Public title
A Prospective Cohort Study on the Diagnosis and Therapeutic Interventions for Adult Airway Foreign Body Cases
Acronym
A Prospective Cohort Study of Adult Airway Foreign Bodies
Scientific Title
A Prospective Cohort Study on the Diagnosis and Therapeutic Interventions for Adult Airway Foreign Body Cases
Scientific Title:Acronym
A Prospective Cohort Study of Adult Airway Foreign Bodies
Region
| Japan |
Condition
Condition
Adult Airway Foreign Body
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical characteristics, foreign body types, removal techniques, procedure-related complications, and outcomes of adult patients (>=18 years) diagnosed with airway foreign bodies and treated with bronchoscopic foreign body removal at participating institutions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of airway foreign body removal
Key secondary outcomes
Age, sex, comorbidities, oxygen saturation on admission, type of foreign body, location of foreign body, foreign body removal techniques (type of bronchoscope and forceps/devices used), anesthesia method (general or local anesthesia), oxygen saturation before and after removal, and adverse events related to foreign body removal.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients suspected of having airway foreign bodies based on medical history, radiologic findings, or endoscopic examination
2. Patients who underwent attempted airway foreign body removal using flexible or rigid bronchoscopy
3. Patients aged 18 years or older
Key exclusion criteria
Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | TOYAMA |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto
TEL
0756419161
shogo106.outmt.bunri.2@gmail.com
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | TOYAMA |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
0756419161
Address
1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto
TEL
0756419161
Homepage URL
shogo106.outmt.bunri.2@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyoto Medical Center
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 Hospital Organization Kyoto Medical Center
Address
1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto
Tel
0756419161
shogo106.outmt.bunri.2@gmail.com
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
| 2026 | Year | 06 | Month | 01 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes.
Management information
Registered date
| 2026 | Year | 05 | Month | 30 | Day |
Last modified on
| 2026 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070601
