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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT05696444
• Lead Sponsor: Medtronic - MITG

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).

Study Timeline

• Study First Submitted: 2022-11-18
• Study Start: 2022-12-14
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-25
• Primary Completion: 2024-10-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint - Surgical Success Rate, defined as the procedure not going into conversion	30 days	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.
Primary Safety Endpoint - Rate of subjects with complications meeting Grade III - Grade V criteria per the Clavien-Dindo Classification System.	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 Outcome Measures

Name	Time	Method
Secondary Endpoint - Intraoperative estimated blood loss (mL).	intraoperative	Intraoperative estimated blood loss shall be collected through the length of the procedure.
Secondary Endpoint - Transfusion Rate through 30 days.	30 days	Transfusion rate shall be collected through 30 days post-procedure
Secondary Endpoint - Rate of device-related conversions	intraoperative	Rate of device-related conversions shall be collected through the length of the procedure.
Secondary Endpoint - Reoperation rate (through 30 days).	30 days	Reoperation rate shall be collected through 30 days post-procedure.
Secondary Endpoint - Mortality rate (through 30 days).	30 days	Mortality rate shall be collected through 30 days post-procedure.
Secondary Endpoint - Overall complication rate from first incision through 30 days post-procedure.	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.
Secondary Endpoint - Operative Time (min)	up to 720 minutes	Operative time shall be collected through the length of the procedure.
Secondary Endpoint - Hospital length of stay (days)	30 days	Hospital length of stay (days) shall be collected through 30 days post-procedure.
Secondary Endpoint - Rate of Device deficiencies (number).	30 days	Rate of device deficiencies (number) shall be collected through 30 days post-procedure.
Secondary Endpoint - Disease-free Survival	5 years	Disease-free survival rate will be assessed through 5 years in oncologic subjects.
Secondary Endpoint - Readmission rate (through 30 days)	30 days	Readmission rate shall be collected though 30 days post-procedure.
Secondary Endpoint - Overall survival rate	5 years	Overall survival rate will be assessed through 5 years in oncologic subjects.
Secondary Endpoint - Progression-free survival	5 years	Progression-free survival rate will be assessed through 5 years in oncologic subjects.

Trial Locations

Locations (6)

University of Chiago; 🇺🇸 Chicago, Illinois, United States

City of Hope; 🇺🇸 Duarte, California, 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