Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Running, not enrolling · Not applicable
Conditions studied: Bladder Cancer, Prostate Cancer, Kidney Cancer, Pelvic Tumor, Interstitial Cystitis, Congenital Abnormalities, End Stage Renal Disease, Renal Tumor, Kidney Injury
In brief
This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
Key facts
- Study ID
- NCT05696444
- Run by
- Medtronic - MITG
- People needed
- 144
- Starts
- 2022-12-14
- Expected to finish
- 2030-01-31
- Last updated by the study team
- 2025-11-25
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- City of Hope — Duarte, California, United States
- University of Chiago — Chicago, Illinois, 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
Full record on ClinicalTrials.gov
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