UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016204
Receipt number R000018803
Scientific Title Resonance Metallic Ureteral Stent for ureteral stenosis due to malignant disease
Date of disclosure of the study information 2015/01/13
Last modified on 2015/01/13 16:58:18

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Basic information

Public title

Resonance Metallic Ureteral Stent for ureteral stenosis due to malignant disease

Acronym

Resonance Metallic Ureteral stent

Scientific Title

Resonance Metallic Ureteral Stent for ureteral stenosis due to malignant disease

Scientific Title:Acronym

Resonance Metallic Ureteral stent

Region

Japan


Condition

Condition

ureteral stenosis due to gastroenterological, gynecological, or urogolical tumor (excluding cases in which the primary disease)

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the usefulness of the Resonance Metallic Ureteral stent, the first metallic ureteral stent in Japnan, to treat ureteral stenosis due to extrinsic compression.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Period of patency of metallic ureteral stent

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

ureteral stenosis due to gastroenterological, gynecological, or urological tumor

Key exclusion criteria

patients who may not be able to visit hospital for follow-up.
patients who have ureteral stenosis that is clearly caused by cancer of the ureteral cancer of renal pelvic cancer.
patients who have paritipated in this study once before.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Miyazaki

Organization

Faculty of Medicne, University of Tsukuba

Division name

Department of Urology

Zip code


Address

1-1-1 Tennodai Tsukuba Ibaraki Japan

TEL

0298533223

Email

jmiyazaki@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jun Miyazaki

Organization

Metallic stent research group

Division name

Department of Urology

Zip code


Address

1-1-1 Tennodai Tsukuba Ibaraki Japan

TEL

0298533223

Homepage URL


Email

jmiyazaki@md.tsukuba.ac.jp


Sponsor or person

Institute

Metallic stent research group

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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 01 Month 13 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

Preinitiation

Date of protocol fixation

2014 Year 12 Month 26 Day

Date of IRB


Anticipated trial start date

2015 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

Hydronephrosis, body temperature, uninalysis, urine culture, IPSS, and OABSS have been obtained pre, third, sixth, ninth and twelveth months.


Management information

Registered date

2015 Year 01 Month 13 Day

Last modified on

2015 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018803


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name