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.
Conditions
Interventions
None listed
Sponsors
Vorpal Technologies K.K
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients undergoing prostatectomy with the AQUABEAM Robotic System in men with lower urinary tract symptoms due to benign prostatic hyperplasia
Exclusion criteria
Exclusion criteria: N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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 | — |
Countries
Japan
Contacts
Public ContactSatoko Inoue
Vorpal Technologies K.K Regulatory Affairs
Outcome results
None listed