UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012766
Receipt number R000014916
Scientific Title Percutaneus puncture into renal caryx and observation in upper urinary tract using HDIG scope combined with puncture needle
Date of disclosure of the study information 2014/01/06
Last modified on 2014/01/06 20:40:20

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Basic information

Public title

Percutaneus puncture into renal caryx and observation in upper urinary tract using HDIG scope combined with puncture needle

Acronym

HDIG scope combined with puncture needle

Scientific Title

Percutaneus puncture into renal caryx and observation in upper urinary tract using HDIG scope combined with puncture needle

Scientific Title:Acronym

HDIG scope combined with puncture needle

Region

Japan


Condition

Condition

nenal stone

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and effectiveness of 19G puncture needle combined with HDIG scope

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

safety and effectiveness of 19G puncture needle combined with HDIG scope

Key secondary outcomes

adverse events


Base

Study type


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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

puncuture by needle combined with HDIG scope

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient with renal stone and plan of percutaneus nephrolithotomy

Key exclusion criteria

without concent

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromi Kumon

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Urology

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan

TEL

-81-86-235-7287

Email

kumon@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichiro Wada

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Urology

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan

TEL

+81-86-235-7287

Homepage URL


Email

gmd17055@s.okadai.jp


Sponsor or person

Institute

Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name



Funding Source

Organization

Fukushima Prefecture

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

SUMITA OPTICAL GLASS, Inc.
Takei Medical & Optical Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1

m14004

Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

岡山大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 06 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

2013 Year 06 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 19 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 06 Day

Last modified on

2014 Year 01 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014916


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name