UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042044 |
|---|---|
| Receipt number | R000047984 |
| Scientific Title | Prospective observational study of curative total prostatectomy using domestic surgery support robot, "hinotori" |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2020/10/07 20:49:50 |
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Basic information
Public title
Clinical study of domestic surgery support robot, "hinotori"
Acronym
hinotori
Scientific Title
Prospective observational study of curative total prostatectomy using domestic surgery support robot, "hinotori"
Scientific Title:Acronym
Hinotori-OS
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
margin negative
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
margin negative
Key secondary outcomes
1. Recovery of urinary continence based on EPIC score at 90d, 180d, 1y, 2y, 3y, 4y, 5y
2. Recovery of sexual function based on EPIC score at 90d, 180d, 1y, 2y, 3y, 4y, 5y
3. Total points of urination status based on EPIC domain score at 90d, 180d, 1y, 2y, 3y, 4y, 5y
4. Rate of Post/Pre total points of sexual function based on EPIC domain score at 90d, 180d, 1y, 2y, 3y, 4y, 5y
5. Achievement of Trifecta at 90d, 180d, 1y, 2y, 3y, 4y, 5y
6. Console time
7. Total surgery time
8. Total sum time of preparation and cleanup of surgery support robot
9. Overall survival
10. Non-clinical recurrence period
11. Non-biochemical recurrence period
12. Adverse events
13. Trouble of surgery support robot
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
Key inclusion criteria
Prospective subjects
1. Total prostatectomy
2. 20 yrs or older
3.Written consent from the individual regarding research participation.
Retrospective subjects
1. Done total prostatectomy using DVSS
2. 20 yrs or older
Key exclusion criteria
Prospective subjects
1.Operated neoadjuvant therapy
2.Judged as an inappropriate patient by the investigator or sub-investigator at the hospital (site) for any other reasons
Retrospective subjects
1. Operated neoadjuvant therapy
2. Refusal to participate in opt out
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Fujisawa |
Organization
Kobe University Hospital
Division name
Urology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6155
masato@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Hinata |
Organization
Kobe University Hospital
Division name
Urology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6155
Homepage URL
https://www.hosp.kobe-u.ac.jp/department/department/hinyou.html
hinata@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Urology, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Medicaroid Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Kobe University Hospital
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
http://www.hosp.kobe-u.ac.jp/ctrc/
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
神戸大学（兵庫県） Kobe University Hospital（Hyogo prefecture）
徳島大学（徳島県） Tokushima University Hospital（Tokushuma prefecture）
和歌山県立医科大学（和歌山県） WAKAYAMA MEDICAL UNIVERSITY HOSPITAL（Wakayama prefecture）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 15 | 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
| 2020 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 10 | Month | 07 | Day |
Last modified on
| 2020 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047984
