UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015473
Receipt number R000017982
Scientific Title The efficacy and safety of TachoSil as haemostatic treatment in robot assisted radical prostatectomy
Date of disclosure of the study information 2014/10/25
Last modified on 2014/10/20 07:03:44

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Basic information

Public title

The efficacy and safety of TachoSil as haemostatic treatment in robot assisted radical prostatectomy

Acronym

The confirmation of efficacy for TachoSil in RARP

Scientific Title

The efficacy and safety of TachoSil as haemostatic treatment in robot assisted radical prostatectomy

Scientific Title:Acronym

The confirmation of efficacy for TachoSil in RARP

Region

Japan


Condition

Condition

Prostatic cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

the confirmation of hemostasis for RARP

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

laboratory data(Hgb,WBC,Plt,CRP,PT,APTT)

Key secondary outcomes



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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Tacho Sil for RARP with nerve sparing

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

75 years-old >=

Gender

Male

Key inclusion criteria

none

Key exclusion criteria

none

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takenaka Atushi

Organization

Tottori University Faculty of Medicine

Division name

Division of Urology, Department of Surgery

Zip code


Address

36-1 Nishi-cho, Yonago, Tottori 683-8504, Japan

TEL

0859-38-6607

Email

masagori0120@med.tottori-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name masago toshihiko

Organization

Tottori University Faculty of Medicine

Division name

Division of Urology, Department of Surgery

Zip code


Address

36-1 Nishi-cho, Yonago, Tottori 683-8504, Japan

TEL

0859-38-6607

Homepage URL


Email

masagori0120@med.tottori-u.ac.jp


Sponsor or person

Institute

Division of Urology, Department of Surgery, Tottori University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2014 Year 10 Month 25 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 01 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 11 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 20 Day

Last modified on

2014 Year 10 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017982


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name