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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023610
Receipt No. R000027184
Scientific Title Evaluation of the usefulness of personalized 3D image software and printed model in partial nephrectomy
Date of disclosure of the study information 2016/09/01
Last modified on 2018/08/18

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Basic information
Public title Evaluation of the usefulness of personalized 3D image software and printed model in partial nephrectomy
Acronym Evaluation of the usefulness of personalized 3D image software and printed model in partial nephrectomy
Scientific Title Evaluation of the usefulness of personalized 3D image software and printed model in partial nephrectomy
Scientific Title:Acronym Evaluation of the usefulness of personalized 3D image software and printed model in partial nephrectomy
Region
Japan

Condition
Condition renal tumor
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of 3D imaging soft,CMMed, and personalized 3D printed model as simulation in partial nephrectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3D imaging soft
validity of expected feeding artery

3D printed model
tumor excised plane
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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 intravenous administration of ICG ( indocyanine green)
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 1) PS 0 or 1
2) 20 years old over at the acquisition of the consent
3) no severe abnormality of cardioplumonary, liver and renal function
4) contrast CT is performed
5) no contraindication of administration of ICG
6) the written consent of the patient has been obtained for this clinical trial
Key exclusion criteria When there is request of the cancellation
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Yoshida
Organization Shiga university of medical science
Division name department of urology
Zip code
Address Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL 077-548-2273
Email hquro@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Yoshida
Organization Shiga university of medical science
Division name department of urology
Zip code
Address Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL 077-548-2273
Homepage URL
Email hquro@belle.shiga-med.ac.jp

Sponsor
Institute Shiga university of medical science
Institute
Department

Funding Source
Organization Shiga university of medical science
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
2016 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 09 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
2016 Year 08 Month 12 Day
Last modified on
2018 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027184

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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