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

NCT ID: NCT05696444

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2030-01-31

Brief Summary

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

Detailed 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).

Conditions

Bladder Cancer; Prostate Cancer; Kidney Cancer; Pelvic Tumor; Interstitial Cystitis; Congenital Abnormalities; End Stage Renal Disease; Renal Tumor; Kidney Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic Assisted Surgery (RAS) Urologic Surgery

Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).

Group Type: OTHER

RAS Prostatectomy

Intervention Type: DEVICE

Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.

RAS Cystectomy

Intervention Type: DEVICE

Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.

RAS Nephrectomy

Intervention Type: DEVICE

Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.

Interventions

RAS Prostatectomy

Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.

Intervention Type: DEVICE

RAS Cystectomy

Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.

Intervention Type: DEVICE

RAS Nephrectomy

Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

2. Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (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 by a signed and dated informed consent form

Exclusion Criteria

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

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

3. Subjects diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants 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 24 months; oncology subjects considered for nephrectomy with a life expectancy less than 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., prisoners or those without sufficient mental capacity)

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

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Abern, MD

Role: STUDY_CHAIR

Duke Medical Center

Locations

City of Hope

Duarte, California, United States

University of Chiago

Chicago, Illinois, United States

Mount Sinai

New York, New York, United States

Duke Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Swedish Medical Center

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MDT19051EINURO

Identifier Type: -

Identifier Source: org_study_id