UMIN-CTR Clinical Trial

Basic information
Public title	Robot-assisted laparoscopic pyeloplasty for ureteropelvic junction obstruction
Acronym	Robot-assisted laparoscopic pyeloplasty
Scientific Title	Robot-assisted laparoscopic pyeloplasty for ureteropelvic junction obstruction
Scientific Title:Acronym	Robot-assisted laparoscopic pyeloplasty
Region	Japan

Condition
Condition	Ureteropelvic junction obstruction
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To certify the efficacy and safety of robot-assisted laparoscopic pyeloplasty, and to provide more minimally invasive surgery for patients with ureteropelvic junction obstruction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Resolution of ureteropelvic junction obstruction, and preserve of kidney function
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	Device,equipment
Interventions/Control_1	Da vinci S surgical system
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	1 years-old <=
Age-upper limit	76 years-old >
Gender	Male and Female
Key inclusion criteria	1)patients with ureteropelvic junction obstruction 2)body weight of patient is above 10kg 3)written approval of patient or patient's family
Key exclusion criteria	1)severe cardiac disease 2)past open surgery with disadvantage for robotic surgery 3)uncontrolled infection 4)other congenital disorder with disadvantage for robotic surgery 5)psychiatric disorder 6)pregnant women 7)bleeding tendency
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Keiichi Middle name Last name Tozawa
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-853-8266
Email	toza@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Mizuno
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Pediatric Urology
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-853-8266
Homepage URL
Email	kmizuno@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Nagoya City University Hospital
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	Nagoya City University
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel	052-851-5511
Email	kmizuno@med.nagoya-cu.ac.jp

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 02 Month 25 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	Completed
Date of protocol fixation	2012 Year 05 Month 31 Day
Date of IRB	2012 Year 06 Month 11 Day
Anticipated trial start date	2012 Year 12 Month 10 Day
Last follow-up date	2020 Year 10 Month 23 Day
Date of closure to data entry	2021 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 25 Day
Last modified on	2022 Year 10 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024457