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
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
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
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
