UMIN-CTR Clinical Trial

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
Email	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
Email	hinata@med.kobe-u.ac.jp

Sponsor
Institute	Department of Urology, Kobe University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047984