NCT05766163

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate

Comparative Evaluation of New Surgical Robotic Platforms for the Radical Prostatectomy Procedure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The object of this exploratory clinical trial is to evaluate post-operative complications in a population that underwent Robotic Assisted Radical Prostatectomy (RARP) made with multiple platforms: * DaVinci; * Hugo; * Versius. The questions it aims to answer are: * Does the estimation of the post-operative complications suggest something? * Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable? Participants will be invited to fill out questionnaires and join one of these three groups: 1. surgery with the daVinci platform; 2. surgery with the Hugo platform; 3. surgery with the Versius platform.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	DaVinci RARP	Assisted-robotic radical prostatectomy.
DEVICE	Hugo RARP	Assisted-robotic radical prostatectomy.
DEVICE	Versius RARP	Assisted-robotic radical prostatectomy.

Timeline

• Start date: 2023-03-14
• Primary completion: 2024-03-01
• Completion: 2024-09-01
• First posted: 2023-03-13
• Last updated: 2023-04-12

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study