UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051331 |
|---|---|
| Receipt number | R000056307 |
| Scientific Title | AQUABEAM Robotic System Use-Results Survey |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2025/09/29 15:07:20 |
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Basic information
Public title
AQUABEAM Robotic System Use-Results Survey
Acronym
AQUABEAM Robotic System Use-Results Survey
Scientific Title
AQUABEAM Robotic System Use-Results Survey
Scientific Title:Acronym
AQUABEAM Robotic System Use-Results Survey
Region
| Japan |
Condition
Condition
Patients for whom the Product is used in accordance with the approved purpose of use, indication or effect, method of use and the Appropriate Use Guideline.
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the efficacy and safety of the AQUABEAM Robotic system in the treatment of LUTS due to BPH.
This product was judged to be an item subject to a use-results evaluation at the time of application for manufacturing and marketing approval.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-IPSS score change from baseline up to 3 months
-Percentage of patients leading to blood transfusions or Clavien-Dindo 3 or higher adverse events up to 30 days after the procedure
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients undergoing prostatectomy with the AQUABEAM Robotic System in men with lower urinary tract symptoms due to benign prostatic hyperplasia
Key exclusion criteria
N/A
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Tsugawa |
Organization
Vorpal Technologies K.K
Division name
Regulatory Affaires
Zip code
161-0034
Address
Oval Shinjuku Building, 3-10-8 Kami-Ochiai, Shinjuku-ku, Tokyo
TEL
+81(3)5544-8340
Hiroshi.Ichinose@mcra.com
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Inoue |
Organization
Vorpal Technologies K.K
Division name
Regulatory Affairs
Zip code
161-0034
Address
Oval Shinjuku Building, 3-10-8 Kami-Ochiai, Shinjuku-ku, Tokyo
TEL
+81(3)5544-8340
Homepage URL
Satoko.Inoue@mcra.com
Sponsor or person
Institute
Vorpal Technologies K.K
Institute
Department
Personal name
Funding Source
Organization
PROCEPT BioRobotics
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2023 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 07 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056307
