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Active, Not Recruiting

NCT Number: NCT05696444

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bladder Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystitis Cystitis, Interstitial Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Interstitial Cystitis Kidney Cancer Kidney Diseases Kidney Failure, Chronic Kidney Injury Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Neoplasms Pelvic Tumor Prostate Cancer Prostatic Diseases Prostatic Neoplasms Renal Insufficiency Renal Insufficiency, Chronic Renal Tumor Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope, Duarte, California, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

RAS Prostatectomy

Device

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

RAS Cystectomy

Device

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

RAS Nephrectomy

Device

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

Primary outcomes

  1. Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion

    Time frame: During surgical procedure

    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.

  2. Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.

    Time frame: 30 days

    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

Secondary outcomes

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

    Time frame: 30 days

    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.

  2. Secondary Endpoint - Operative Time (Min)

    Time frame: up to 720 minutes

    Operative time shall be collected through the length of the procedure.

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

    Time frame: intraoperative

    Intraoperative estimated blood loss shall be collected through the length of the procedure.

  4. Secondary Endpoint - Transfusion Rate Through 30 Days.

    Time frame: 30 days

    Transfusion rate shall be collected through 30 days post-procedure

  5. Secondary Endpoint - Rate of Device-related Conversions

    Time frame: intraoperative

    Rate of device-related conversions shall be collected through the length of the procedure.

  6. Secondary Endpoint - Hospital Length of Stay (Days)

    Time frame: 30 days

    Hospital length of stay (days) shall be collected through 30 days post-procedure.

  7. Secondary Endpoint - Readmission Rate (Through 30 Days)

    Time frame: 30 days

    Readmission rate shall be collected though 30 days post-procedure.

  8. Secondary Endpoint - Reoperation Rate (Through 30 Days).

    Time frame: 30 days

    Reoperation rate shall be collected through 30 days post-procedure.

  9. Secondary Endpoint - Mortality Rate (Through 30 Days).

    Time frame: 30 days

    Mortality rate shall be collected through 30 days post-procedure.

  10. Secondary Endpoint - Progression-free Survival

    Time frame: 5 years

    Progression-free survival rate will be assessed through 5 years in oncologic subjects.

  11. Secondary Endpoint - Disease-free Survival

    Time frame: 5 years

    Disease-free survival rate will be assessed through 5 years in oncologic subjects.

  12. Secondary Endpoint - Overall Survival

    Time frame: 5 years

    Overall survival rate will be assessed through 5 years in oncologic subjects.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2030
First posted
Jan 25, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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