Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform (URO-ROBOT-2023)

February 19, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

HUGO RAS Robotic Platform for Radical Prostatectomy and Partial Nephrectomy: Comparison with the Da Vinci Robotic Platform

The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN). The study is divided into a patient enrolment and robot-assisted treatment phase, followed by a phase of oncological and functional follow-up. Once enrolled, patients will be randomized to undergo treatment using either the Da Vinci Xi platform (Intuitive Surgical) or the HUGO™ RAS platform (Medtronic) according to block randomization.

Patients with prostate cancer (Group A), enrolled according to inclusion criteria, will be randomized to undergo RP treatment with the Da Vinci Xi platform (control group) or RP treatment with the HUGO™ RAS platform (study group).

Patients with kidney cancer (Group B), enrolled according to inclusion criteria, will be randomized to undergo PN treatment with the Da Vinci Xi platform or PN treatment with the HUGO™ RAS platform.

If the surgical, oncological, and functional outcomes observed following radical prostatectomy and partial nephrectomy performed with the HUGO RAS platform prove to be equivalent to those obtained with the Da Vinci Xi platform, it should lead to a progressive increase in the use of the HUGO RAS platform, resulting in a reduction in the overall costs associated with robotic urological surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients with Prostate Cancer (Group A)

  • Age ≥ 18 years.
  • Life expectancy greater than 10 years.
  • Diagnosis of prostate cancer following prostate needle biopsy.
  • Clinical stage cT1-T3b, N0-1 disease.
  • Positive anesthetic fitness assessment for robot-assisted radical prostatectomy.
  • Provision of informed consent for the study.

Patients with Kidney Cancer (Group B)

  • Age ≥ 18 years.
  • Radiological diagnosis of organ-confined kidney cancer at clinical stage T1a or T1b.
  • Underwent CT and/or MRI of the abdomen with contrast medium.
  • Positive anesthetic fitness assessment for robot-assisted partial nephrectomy.
  • Provision of informed consent for the study.

Exclusion Criteria:

Patients with Prostate Cancer (Group A)

  • Expression of a preference for radical treatment other than surgery (e.g., external radiotherapy).
  • Metastatic prostate cancer (M1).
  • Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.

Patients with Kidney Cancer (Group B)

  • Indication for radical nephrectomy.
  • Metastatic kidney cancer (M1).
  • Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: prostate cancer
Patients with prostate cancer (Group A), enrolled according to the inclusion criteria, are randomized to undergo radical prostatectomy (RP) using either the Da Vinci Xi platform (control group) or the HUGO™ RAS platform (study group).
Procedure: Radical prostatectomy
Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform
Active Comparator: kidney cancer
patients with kidney cancer (Group B), enrolled according to the inclusion criteria, are randomized to undergo partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform.
Procedure: Partial nephrectomy
partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications
Time Frame: 90 days

To demonstrate the equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications observed within 90 days post-surgery. This evaluation will be conducted separately for:

Patients undergoing radical prostatectomy (RP). Patients undergoing partial nephrectomy (PN).

perioperative complication rate of grade greater than or equal to Clavien-Dindo IIIa within 90 days after surgery will be calculated.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators
Time Frame: during surgery
during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times
Time Frame: during surgery
during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Instrument conflicts or malfunctions
Time Frame: during surgery
Instrument conflicts and malfunctions will be calculated (in number and %)
during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss
Time Frame: during surgery
during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay.
Time Frame: up to 4 days
up to 4 days
Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins
Time Frame: 90 days after surgery
90 days after surgery
Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease.
Time Frame: 5 years
5 years
Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time
Time Frame: 5 years
5 years
Oncologic outcomes of PR or PN surgery : Overall survival
Time Frame: 5 years
5 years
Oncologic outcomes of PR or PN surgery : Cancer-specific survival
Time Frame: 5 years
5 years
functional outcomes of PR or PN surgery: - International Index of Erectile Function (IIEF-5) score of recovery of sexual function
Time Frame: 5 years
The possible scores for the IIEF-5 range from 5 to 25, and erectile dysfunction is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
5 years
functional outcomes of PR or PN surgery: - Number of pads used
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eugenio Brunocilla, Prof, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • URO ROBOT 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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