UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018767
Receipt number R000021666
Scientific Title The Safety and Efficacy of Robotic Renal Autotransplantation
Date of disclosure of the study information 2015/08/22
Last modified on 2020/08/25 10:31:34

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Basic information

Public title

The Safety and Efficacy of Robotic Renal Autotransplantation

Acronym

Robotic Renal Autotransplantation

Scientific Title

The Safety and Efficacy of Robotic Renal Autotransplantation

Scientific Title:Acronym

Robotic Renal Autotransplantation

Region

Japan


Condition

Condition

Cases required for renal autotransplantation such as renal artery stenosis, renal vessel abnormality, renal mass, ureteral diseases, renal trauma, ureteral trauma, urinary stones.

Classification by specialty

Surgery in general Vascular surgery Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of robotic renal autotransplantation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Kidney sparing

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Perform robotic renal autotransplantation

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

Cases required for renal autotransplantation such as renal artery stenosis, renal vessel abnormality, renal mass, ureteral diseases, renal trauma, ureteral trauma, urinary stones.

Key exclusion criteria

Cases not required for renal autotransplantation.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Motoo
Middle name
Last name Araki

Organization

Okayama University Hospital

Division name

Urology

Zip code

7008558

Address

2-5-1 Shikata-cho Okayama-shi Okayama-ken 700-8558 Japan

TEL

086-235-7287

Email

motoosh@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name Motoo
Middle name
Last name Araki

Organization

Okayama University Hospital

Division name

Urology

Zip code

7008558

Address

2-5-1 Shikata-cho Okayama-shi Okayama-ken 700-8558 Japan

TEL

086-235-7287

Homepage URL


Email

motoosh@md.okayama-u.ac.jp


Sponsor or person

Institute

Department of Urology, Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

Okayama 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

IRB, Okayama University Hospital

Address

2-5-1 Shikata-cho Okayama-shi Okayama-ken 700-8558 Japan

Tel

086-235-7287

Email

mae6605@adm.okayama-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

2015 Year 08 Month 22 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 10 Month 21 Day

Date of IRB

2014 Year 09 Month 03 Day

Anticipated trial start date

2015 Year 07 Month 01 Day

Last follow-up date

2025 Year 07 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 22 Day

Last modified on

2020 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021666


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name