UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057296 |
|---|---|
| Receipt number | R000065497 |
| Scientific Title | A prospective observational study on the diagnostic yield and safety of bronchoscopy guided by a Mobile 3D C-arm system for ground-glass opacity predominant lesions under moderate or deep sedation with spontaneous breathing. |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/03/16 05:19:45 |
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Basic information
Public title
A prospective observational study on the diagnostic yield and safety of bronchoscopy guided by a Mobile 3D C-arm system for ground-glass opacity predominant lesions under moderate or deep sedation with spontaneous breathing.
Acronym
A study on the utility of bronchoscopy guided by a Mobile 3D C-arm system for ground-glass opacity predominant lesions
Scientific Title
A prospective observational study on the diagnostic yield and safety of bronchoscopy guided by a Mobile 3D C-arm system for ground-glass opacity predominant lesions under moderate or deep sedation with spontaneous breathing.
Scientific Title:Acronym
A study on the utility of bronchoscopy guided by a Mobile 3D C-arm system for ground-glass opacity predominant lesions
Region
| Japan |
Condition
Condition
lung tumor
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the usefulness of biopsy guided by a Mobile 3D C-arm system for GGO-predominant pulmonary lesions during bronchoscopy under spontaneous breathing with moderate to deep sedation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total diagnostic yield
Key secondary outcomes
Tissue diagnostic yield, cytology diagnostic yield, lesion access yield using 3D imaging, comparison of lesion access between radial EBUS findings and 3D imaging, procedure time, radiation exposure, number of scans, complications, feasibility and results of genetic testing for lung cancer, and diagnostic yield and lesion access yield using 3D imaging in subgroups (lesion size, location, presence or absence of CT bronchus sign, lesion characteristics, presence or absence of CPAP/pressure support, type of bronchoscope used, presence or absence of cryobiopsy, etc.).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Having a small GGO-predominant pulmonary lesion suspected to be a lung tumor with a lesion diameter of 30 mm or less.
Planning to undergo diagnostic bronchoscopy using a Mobile 3D C-arm system under moderate to deep sedation while maintaining spontaneous breathing for the diagnosis of the above lesion.
Being 20 years of age or older at the time of obtaining consent.
Having provided written informed consent for participation in this study.
Key exclusion criteria
Cases where bronchoscopy is considered difficult due to a severe condition.
Cases with a history of hypersensitivity to lidocaine, midazolam, or fentanyl.
Cases with liver disease or blood disorders associated with coagulation abnormalities.
Cases undergoing antiplatelet or anticoagulant therapy where appropriate drug withdrawal is difficult.
Cases of pregnancy.
Other cases where the attending physician deems the subject unsuitable for participation.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Matsusaka Municipal Hospital
Division name
Department of Respiratory Medicine
Zip code
515-0073
Address
1550 Tonomachi, Matsusaka 515-0073, Mie, Japan
TEL
0598231515
iwbd0524@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Matsusaka Municipal Hospital
Division name
Department of Respiratory Medicine
Zip code
515-0073
Address
1550 Tonomachi, Matsusaka 515-0073, Mie, Japan
TEL
0598231515
Homepage URL
mchsakaguchi@city-hosp.matsusaka.mie.jp
Sponsor or person
Institute
Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
This research received no external funding.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsusaka Municipal hospital
Address
1550 Tonomachi, Matsusaka 515-0073, Mie, Japan
Tel
0598231515
mchsakaguchi@city-hosp.matsusaka.mie.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
| 2025 | Year | 03 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not otherwise specified.
Management information
Registered date
| 2025 | Year | 03 | Month | 16 | Day |
Last modified on
| 2025 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065497
