UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008420 |
|---|---|
| Receipt number | R000009907 |
| Scientific Title | Preoperativ marking method using gold-markers for a small lung nodule unable to be identified under thoracoscopy |
| Date of disclosure of the study information | 2012/07/12 |
| Last modified on | 2018/09/17 13:48:05 |
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Basic information
Public title
Preoperativ marking method using gold-markers for a small lung nodule unable to be identified under thoracoscopy
Acronym
Preoperative insertion of gold-markers for a small lung nodule
Scientific Title
Preoperativ marking method using gold-markers for a small lung nodule unable to be identified under thoracoscopy
Scientific Title:Acronym
Preoperative insertion of gold-markers for a small lung nodule
Region
| Japan |
Condition
Condition
undiagnosed small lung nodule
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Safety
Prevention from a complication of air embolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse effect during one month after surgery
Key secondary outcomes
The number of marker left in the body
Histopathological examination of lung nodule
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Insertion of gold markers under bronchoscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Undiagnosed small lung nodole
Case required lung biopsy by surgery
Patient agreeded with this research
Key exclusion criteria
Patient not agreeded with this research
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironori Ishida |
Organization
Saitama Medical University International center
Division name
Genaral Thoracic Surgery
Zip code
Address
1397-1 Yamane, Hidaka-shi, Saitama
TEL
042-984-4111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Ishida |
Organization
Saitama Medical University International center
Division name
Genaral Thoracic Surgery
Zip code
Address
1397-1 Yamane, Hidaka-shi, Saitama
TEL
042-984-4111
Homepage URL
Sponsor or person
Institute
Saitama Medical University International center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International 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
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
埼玉医科大学国際医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 13 | 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
| 2012 | Year | 07 | Month | 12 | Day |
Last modified on
| 2018 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009907
