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

NCT05696444 | Active Not Recruiting Results FDA Device

• 1 other identifier: MDT19051EINURO
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.

  30 days

• Secondary Endpoint - Operative Time (Min)

  up to 720 minutes

• Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).

  intraoperative

• Secondary Endpoint - Transfusion Rate Through 30 Days.

  30 days

• Secondary Endpoint - Rate of Device-related Conversions

  intraoperative

Study Arms (1)

Robotic Assisted Surgery (RAS) Urologic Surgery

OTHER

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

Device: RAS Prostatectomy; Device: RAS Cystectomy; Device: RAS Nephrectomy

Interventions

RAS Prostatectomy DEVICE

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

Robotic Assisted Surgery (RAS) Urologic Surgery

RAS Cystectomy DEVICE

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

Robotic Assisted Surgery (RAS) Urologic Surgery

RAS Nephrectomy DEVICE

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

Robotic Assisted Surgery (RAS) Urologic Surgery

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (age ≥ 22 years) as required by local law
• Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure
• Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
• The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form

You may not qualify if:

• Subjects for which minimally invasive surgery is contraindicated as determined by the Investigator
• Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
• 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
• 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.
• Female subjects pregnant at the time of the surgical procedure.
• Subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
• Subjects who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
• Subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (6)

City of Hope

Duarte, California, 91010, United States

Location

University of Chiago

Chicago, Illinois, 60612, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Prostatic Neoplasms; Kidney Neoplasms; Pelvic Neoplasms; Cystitis, Interstitial; Congenital Abnormalities; Kidney Failure, Chronic; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Kidney Diseases; Cystitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Michele Masters, Sr. Clinical Research Program Manager
• Organization: Medtronic

michele.masters@medtronic.com

4848948925

Study Officials

• Michael Abern, MD

  Duke Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: January 25, 2023
• Study Start: December 14, 2022
• Primary Completion: October 10, 2024
• Study Completion (Estimated): January 31, 2030
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)