Active — Not RecruitingNot Applicable

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

United States144 participantsStarted 2022-12-14

Plain-language summary

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

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

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

Timeframe: During surgical procedure

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

Timeframe: 30 days

NCT IDNCT05696444

SponsorMedtronic - MITG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-10

Results submitted2025-10-09

Who can participate