UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the usefulness of personalized 3D image software and printed model in partial nephrectomy
Title of the study (Brief title)	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	Tetsuya Yoshida
Organization	Shiga university of medical science
Division name	department of urology
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	Tetsuya Yoshida
Organization	Shiga university of medical science
Division name	department of urology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027184