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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

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