Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform

NCT06844513 | Not Yet Recruiting

• 1 other identifier: URO ROBOT 2023
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer (Adenocarcinoma); Renal Cancer

Outcome Measures

Primary Outcomes (1)

• Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications

  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 Outcomes (12)

• Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators

  during surgery

• Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times

  during surgery

• Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Instrument conflicts or malfunctions

  during surgery

• Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss

  during surgery

• Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay.

  up to 4 days

Study Arms (2)

prostate cancer

ACTIVE COMPARATOR

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

kidney cancer

ACTIVE COMPARATOR

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

Interventions

Radical prostatectomy PROCEDURE

Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform

prostate cancer

Partial nephrectomy PROCEDURE

partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform

kidney cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with Prostate Cancer (Group A)
• Expression of a preference for radical treatment other than surgery (e.g., external radiotherapy).
• Metastatic prostate cancer (M1).
• Patients with Kidney Cancer (Group B)
• Indication for radical nephrectomy.
• Metastatic kidney cancer (M1).

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases

Study Officials

• Eugenio Brunocilla, Prof, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugenio Brunocilla, Prof, MD

CONTACT

+39 051 2142374; eugenio.brunocilla@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 25, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2033
• Last Updated: February 25, 2025

Record last verified: 2024-12

Locations

IT (1)