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 | 2023/12/01 09:53:46 |
AQUABEAM Robotic System Use-Results Survey
AQUABEAM Robotic System Use-Results Survey
AQUABEAM Robotic System Use-Results Survey
AQUABEAM Robotic System Use-Results Survey
Japan |
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.
Urology |
Others
NO
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.
Safety,Efficacy
-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
Observational
Not applicable |
Not applicable |
Male
Patients undergoing prostatectomy with the AQUABEAM Robotic System in men with lower urinary tract symptoms due to benign prostatic hyperplasia
N/A
100
1st name | Shinichi |
Middle name | |
Last name | Tsugawa |
Vorpal Technologies K.K
Regulatory Affaires and Clinical Affairs
103-0021
Nihonbashi Muromachi Bldg. 8F, 3-3-16
+81(3)5544-8340
Shinichi.Tsugawa@vorpaltechnologies.com
1st name | Satoko |
Middle name | |
Last name | Inoue |
Vorpal Technologies K.K
Clinical Affairs
103-0021
Nihonbashi Muromachi Bldg. 8F, 3-3-16
+81(3)5544-8340
Satoko.Inoue@vorpaltechnologies.com
Vorpal Technologies K.K
PROCEPT BioRobotics
Profit organization
N/A
N/A
N/A
N/A
NO
2023 | Year | 07 | Month | 01 | Day |
Unpublished
No longer recruiting
2022 | Year | 11 | Month | 07 | Day |
2023 | Year | 05 | Month | 15 | Day |
2023 | Year | 07 | Month | 01 | Day |
2025 | Year | 06 | Month | 30 | Day |
N/A
2023 | Year | 06 | Month | 13 | Day |
2023 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056307
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |