Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)

NCT ID: NCT06290427

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-06-30

Brief Summary

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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 two currently available platforms:

* DaVinci®;
* Hugo®.

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 two experimental group:

1. surgery with the DaVinci platform;
2. surgery with the Hugo platform.

Detailed Description

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Conditions

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Renal Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DaVinci system

Robot-assisted partial nephrectomy is performed using the DaVinci platform

Group Type ACTIVE_COMPARATOR

DaVinci RAPN

Intervention Type DEVICE

Robot-assisted Partial Nephrectomy with DaVinci® Surgical System

Hugo RAS system

Robot-assisted partial nephrectomy is performed using the Hugo RAS platform

Group Type EXPERIMENTAL

Hugo RAS RAPN

Intervention Type DEVICE

Robot-assisted Partial Nephrectomy with Hugo™ RAS System

Interventions

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DaVinci RAPN

Robot-assisted Partial Nephrectomy with DaVinci® Surgical System

Intervention Type DEVICE

Hugo RAS RAPN

Robot-assisted Partial Nephrectomy with Hugo™ RAS System

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role lead

Responsible Party

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Alessandro Antonelli, MD, Prof

MD, Director of Urology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro AA Antonelli, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Integrata Verona

Locations

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Urology Unit, AOUI Verona

Verona, VR, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro AA Antonelli, MD

Role: CONTACT

+39 0458127701

Facility Contacts

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Alessandro AA Antonelli, MD

Role: primary

+39 0458127701

Unità Ricerca Clinica

Role: backup

+39 0458122844

Other Identifiers

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COMPAR-K

Identifier Type: -

Identifier Source: org_study_id

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