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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008420
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Saitama Medical University International center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009907

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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