UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015448
Receipt number 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 10:48:40

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Division of Urology, Faculty of Medicine, Tottori University

Institute

Department

Personal name



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

Value
https://center6.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