To hear about similar clinical trials, please enter your email below
Trial Title:
Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)
NCT ID:
NCT06290427
Condition:
Renal Carcinoma
Conditions: Official terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Conditions: Keywords:
Robotic-assisted surgery
Partial Nephrectomy
Multiple surgical platforms
Postoperative complications
Operative outcomes
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
DaVinci RAPN
Description:
Robot-assisted Partial Nephrectomy with DaVinci® Surgical System
Arm group label:
DaVinci system
Intervention type:
Device
Intervention name:
Hugo RAS RAPN
Description:
Robot-assisted Partial Nephrectomy with Hugo™ RAS System
Arm group label:
Hugo RAS system
Intervention type:
Device
Intervention name:
Versius® RAPN
Description:
Robot-assisted Partial Nephrectomy with Versius® System
Arm group label:
Versius system
Summary:
The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary
evaluation of postoperative complications specifically focused on robotic partial
nephrectomy (RAPN) procedures using three currently available platforms:
- DaVinci®;
- Hugo®;
- Versius®.
The questions it aims to answer are:
Does the estimation of the post-operative complications suggest something? Are
differences (intra- and post-operative, oncological, functional, technical, and economic)
among the three intervention approaches observable?
Participants will be invited to join one of these three experimental group:
1. surgery with the DaVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patient aged between 18 and 90 years old;
- patient with localized kidney tumor suitable for partial nephrectomy;
- patient able to understand and sign the informed consent;
- patient compliance with the follow-up program.
Exclusion Criteria:
- patient who do not fall within the inclusion age range;
- patient not suitable for partial nephrectomy;
- patient unable to understand and sign the informed consent;
- patient unable to follow the monitoring program;
- patient refusal to participate to the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Urology Unit, AOUI Verona
Address:
City:
Verona
Zip:
37126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandro AA Antonelli, MD
Phone:
+39 0458127701
Email:
alessandro.antonelli@aovr.veneto.it
Contact backup:
Last name:
Unità Ricerca Clinica
Phone:
+39 0458122844
Email:
unita.ricerca.clinica@aovr.veneto.it
Start date:
February 1, 2024
Completion date:
December 2024
Lead sponsor:
Agency:
Azienda Ospedaliera Universitaria Integrata Verona
Agency class:
Other
Source:
Azienda Ospedaliera Universitaria Integrata Verona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06290427