Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate

NCT ID: NCT05766163

Last Updated: 2023-04-12

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

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 radical prostatectomy is carried out through daVinci platform.

Group Type ACTIVE_COMPARATOR

DaVinci RARP

Intervention Type DEVICE

Assisted-robotic radical prostatectomy.

Hugo system

Robot-assisted radical prostatectomy is carried out through Hugo platform.

Group Type EXPERIMENTAL

Hugo RARP

Intervention Type DEVICE

Assisted-robotic radical prostatectomy.

Versius system

Robot-assisted radical prostatectomy is carried out through Versius platform.

Group Type EXPERIMENTAL

Versius RARP

Intervention Type DEVICE

Assisted-robotic radical prostatectomy.

Interventions

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DaVinci RARP

Assisted-robotic radical prostatectomy.

Intervention Type DEVICE

Hugo RARP

Assisted-robotic radical prostatectomy.

Intervention Type DEVICE

Versius RARP

Assisted-robotic radical prostatectomy.

Intervention Type DEVICE

Other Intervention Names

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DaVinci® Surgical System Hugo™ RAS System Versius® Robotic Surgery System

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 and \< 90 years;
* Organ-localized prostate cancer with a surgical indication of radical prostatectomy;
* Informed consent provided.

Exclusion Criteria

* Age \< 18 and \> 90 years;
* Contraindication to radical prostatectomy procedure;
* Non-organ confined prostate cancer;
* Refusal to participate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

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

Director of Urology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro AA Antonelli

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Integrata Verona

Locations

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Urology Unit, AOUI Verona

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro AA Antonelli

Role: CONTACT

+39 0458127701

Facility Contacts

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Alessandro AA Antonelli

Role: primary

+39 0458127701

Unità di Ricerca Clinica

Role: backup

+39 0458122844

Other Identifiers

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COMPAR-P

Identifier Type: -

Identifier Source: org_study_id

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