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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015448
Receipt No. R000015769
Scientific Title The effect of Robot-assisted laparoscopic pyeloplasty for ureteropelvic junction obstruction
Date of disclosure of the study information 2014/11/01
Last modified on 2019/04/21

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Basic information
Public title The effect of Robot-assisted laparoscopic pyeloplasty for ureteropelvic junction obstruction
Acronym The effect of Robot-assisted laparoscopic pyeloplasty
Scientific Title The effect of Robot-assisted laparoscopic pyeloplasty for ureteropelvic junction obstruction
Scientific Title:Acronym The effect of 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 evaluate the feasibility and efficacy of robot-assisted laparoscopic pyeloplasty for ureteropelvic junction obstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the improvement of the hydronephrosis, and the complications after operation.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We perform robot-assisted laparoscopic pyeloplasty
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients diagnosed as ureteropelvic junction obstruction
Key exclusion criteria less than 15 years old
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Takenaka
Organization Faculty of Medicine, Tottori University
Division name Urology
Zip code 6838504
Address 86 nishi-cho, Yonago
TEL 0859-38-6607
Email atake@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name Shuichi
Middle name
Last name Morizane
Organization Faculty of Medicine, Tottori University
Division name Urology
Zip code 6838504
Address 86 nishi-cho, Yonago
TEL 0859-38-6607
Homepage URL
Email morizane@med.tottori-u.ac.jp

Sponsor
Institute Division of Urology, Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization Tottori University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Certified Review Board, Tottori University Hospital
Address 36-1 Nishi-cho, Yonago, Tottori, Japan
Tel 0859-38-7021
Email cert.office@ml.med.tottori-u.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
2014 Year 11 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 Open public recruiting
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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
2014 Year 10 Month 16 Day
Last modified on
2019 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015769

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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