UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preoperative simulation using a three-dimensional printing model for the treatment of staghorn calculi.
Title of the study (Brief title)	Preoperative simulation using a three-dimensional printing model for the treatment of staghorn calculi.
Region	Japan

Condition
Condition	kidney stone
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the efficacy of the preoperative simulation using a three-dimensional model
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	success rate, complication rate
Key secondary outcomes	operative time, blood loss

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	Other
Interventions/Control_1	Operative simulation using a three-dimensional printing model before the percutaneous nephrolithotomy.
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	patients with staghorn calculi who are planning to be treated by percutaneous nephrolithotomy.
Key exclusion criteria	none
Target sample size	30

Research contact person
Name of lead principal investigator	Ryoji Takazawa
Organization	Tokyo Metropolitan Ohtsuka Hospital
Division name	Urology
Address	2-8-1, Minami-Ohtsuka, Toshima-ku, Tokyo
TEL	03-3941-3211
Email	ryoji_takazawa@tmhp.jp

Public contact
Name of contact person	Ryoji Takazawa
Organization	Tokyo Metropolitan Ohtsuka Hospital
Division name	Urology
Address	2-8-1, Minami-Ohtsuka, Toshima-ku, Tokyo
TEL	03-3941-3211
Homepage URL
Email	ryoji_takazawa@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Ohtsuka Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization	Local Government
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	2015 Year 09 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 06 Day
Last modified on	2018 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021888