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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

800

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • 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)

March 31, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2033

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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