UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013227 |
|---|---|
| Receipt number | R000015436 |
| Scientific Title | Bronchoscopic examination with body surface ultrasound guidance for diagnosing peripheral lung lesions. |
| Date of disclosure of the study information | 2014/02/23 |
| Last modified on | 2014/02/23 02:49:14 |
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Basic information
Public title
Bronchoscopic examination with body surface ultrasound guidance for diagnosing peripheral lung lesions.
Acronym
Body surface ultrasound-guided bronchoscopy
Scientific Title
Bronchoscopic examination with body surface ultrasound guidance for diagnosing peripheral lung lesions.
Scientific Title:Acronym
Body surface ultrasound-guided bronchoscopy
Region
| Japan |
Condition
Condition
lung lesion
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We tried to combine the bronchofiberscopy and body surface ultrasound, creating the body surface ultrasound-guided bronchofiberscope (BSUS-BF), and evaluated the utility of this method in diagnosing peripheral lung lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
bronchoscopy with body surface ultrasound guidance
Interventions/Control_2
bronchoscopy without guidance
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Peripheral lung lesions less than or equal to 5 cm in longer axis by CT scan were selected for the study.
Key exclusion criteria
Those who were not suitable for conducting bronchofiberscope were excluded.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kamimura |
Organization
National Center for Global Health and Medicine
Division name
Department of Pulmonology
Zip code
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo, 162-8655 Japan
TEL
03-3202-7181
tdmckamimura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Pulmonology Department
Zip code
Address
Midori-machi 3256, Tachikawa-shi, Tokyo 190-0014, Japan
TEL
042-526-5511
Homepage URL
tdmckamimura@yahoo.co.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
国立国際医療研究センター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 23 | 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
Completed
Date of protocol fixation
| 1997 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1997 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 23 | Day |
Last modified on
| 2014 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015436
| 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 |
