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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024175
Receipt No. R000027833
Scientific Title development of new image-guided procedure utilized by Indocyaning green fluorescence for minimally invasive thoracic surgery
Date of disclosure of the study information 2016/09/26
Last modified on 2016/09/26

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Basic information
Public title development of new image-guided procedure utilized by Indocyaning green fluorescence for minimally invasive thoracic surgery
Acronym development of new image-guided procedure utilized by Indocyaning green fluorescence for minimally invasive thoracic surgery
Scientific Title development of new image-guided procedure utilized by Indocyaning green fluorescence for minimally invasive thoracic surgery
Scientific Title:Acronym development of new image-guided procedure utilized by Indocyaning green fluorescence for minimally invasive thoracic surgery
Region
Japan

Condition
Condition lung neoplasm
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluating the validity and efficacy of infrared fluorescence guided minimally invasive pulmonary resection for small-sized pulmonary nodules
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the rate of successful resection of pulmonary nodules
Key secondary outcomes

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 the injection of tiny volume (100 microlitter, 0.025mg/ml) of ICG to pulmonary nodules. (
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
90 years-old >=
Gender Male and Female
Key inclusion criteria the surgical patients who is taking pulmonary resection of small-sized pulmonary nodules
Key exclusion criteria N/A
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Anayama
Organization Kochi University
Division name Department of surgery II
Zip code
Address Kohasu Okocho Nankoku
TEL 088-880-2375
Email anayamat@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Anayama
Organization Kochi University
Division name Department of surgery II
Zip code
Address Kohasu Okocho Nankoku
TEL 088-880-2375
Homepage URL
Email anayamat@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

Funding Source
Organization Kochi University
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 26 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
Date of protocol fixation
2013 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 28 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
2016 Year 09 Month 26 Day
Last modified on
2016 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027833

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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