Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO) (NCT05696444) | Clinical Trial Compass
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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
Timeframe: During surgical procedure
2
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.