Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

Last updated: November 13, 2025
Sponsor: Medtronic - MITG
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Prostate Cancer

Urinary Incontinence

Pelvic Cancer

Treatment

RAS Nephrectomy

RAS Cystectomy

RAS Prostatectomy

Clinical Study ID

NCT05696444
MDT19051EINURO
  • Ages > 22
  • All Genders

Study Summary

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult subjects (age ≥ 22 years) as required by local law

  2. Subject has been indicated for a radical prostatectomy, radical cystectomy, ornephrectomy (partial or radical) surgical procedure

  3. Subject is an acceptable candidate for a fully robotic assisted surgical procedure,a laparoscopic surgical procedure, or an open surgical procedure

  4. The subject is willing to participate and consents to participate, as documented bya signed and dated informed consent form

Exclusion

Exclusion Criteria:

  1. Subjects for which minimally invasive surgery is contraindicated as determined bythe Investigator

  2. Subjects with comorbidities or medical characteristics, which would preclude thesurgical procedure in the opinion of the Investigator

  3. Subjects diagnosed with a bleeding disorder and/or cannot be removed from theiranticoagulants prior to surgery based on surgeon discretion and standard-of-care

  4. Non-oncology subjects with an estimated life expectancy of less than 6 months;oncology subjects considered for cystectomy with a life expectancy less than 24months; oncology subjects considered for nephrectomy with a life expectancy lessthan 60 months; oncology subjects considered for prostatectomy with less than a 10-year life expectancy.

  5. Female subjects pregnant at the time of the surgical procedure.

  6. Subjects who are considered to be part of a vulnerable population (e.g., prisonersor those without sufficient mental capacity)

  7. Subjects who have participated in an investigational drug or device research studywithin 30 days of enrollment that would interfere with this study

  8. Subjects with active infections including but not limited to pneumonia, urinarytract, cellulitis, or bacteremia

Study Design

Total Participants: 144
Treatment Group(s): 3
Primary Treatment: RAS Nephrectomy
Phase:
Study Start date:
December 14, 2022
Estimated Completion Date:
January 31, 2030

Study Description

A prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic indication will be followed for 30 days post-procedure. Oncologic subjects will be followed annually through 5 years. The study will be conducted in up to 6 investigative sites in the United States of America (USA).

Connect with a study center

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • University of Chiago

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Chiago

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Duke Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke Medical Center

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle 5809844, Washington 5815135 98122
    United States

    Site Not Available

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