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

A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Cancer; Congenital Abnormalities; End Stage Renal Disease; Prostate Cancer; Bladder Cancer; Kidney Injury; Interstitial Cystitis; Renal Tumor; Pelvic Tumor
• Intervention / Treatment: Device: RAS Prostatectomy; Device: RAS Cystectomy; Device: RAS Nephrectomy

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).

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Chiago
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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).

Device: RAS Prostatectomy; Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.; Device: RAS Cystectomy; Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.; Device: RAS Nephrectomy; Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion	The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery.	During surgical procedure
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.	Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure. Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint - Disease-free Survival	Disease-free survival rate will be assessed through 5 years in oncologic subjects.	5 years
Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.	Complication rate: Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.	30 days
Secondary Endpoint - Operative Time (Min)	Operative time shall be collected through the length of the procedure.	up to 720 minutes
Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).	Intraoperative estimated blood loss shall be collected through the length of the procedure.	intraoperative
Secondary Endpoint - Transfusion Rate Through 30 Days.	Transfusion rate shall be collected through 30 days post-procedure	30 days
Secondary Endpoint - Rate of Device-related Conversions	Rate of device-related conversions shall be collected through the length of the procedure.	intraoperative
Secondary Endpoint - Hospital Length of Stay (Days)	Hospital length of stay (days) shall be collected through 30 days post-procedure.	30 days
Secondary Endpoint - Readmission Rate (Through 30 Days)	Readmission rate shall be collected though 30 days post-procedure.	30 days
Secondary Endpoint - Reoperation Rate (Through 30 Days).	Reoperation rate shall be collected through 30 days post-procedure.	30 days
Secondary Endpoint - Mortality Rate (Through 30 Days).	Mortality rate shall be collected through 30 days post-procedure.	30 days
Secondary Endpoint - Progression-free Survival	Progression-free survival rate will be assessed through 5 years in oncologic subjects.	5 years
Secondary Endpoint - Overall Survival	Overall survival rate will be assessed through 5 years in oncologic subjects.	5 years

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Study Chair: Michael Abern, MD, Duke Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Actual): October 10, 2024
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Renal Insufficiency; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Renal Insufficiency, Chronic; Cystitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Congenital Abnormalities; Prostatic Neoplasms; Pelvic Neoplasms; Carcinoma, Renal Cell; Urinary Bladder Neoplasms; Kidney Failure, Chronic; Kidney Neoplasms; Cystitis, Interstitial
• Other Study ID Numbers: MDT19051EINURO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes