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NCT07901049
Hugo™ RAS Urology Post-Market Clinical Study
Conditions: Prostatectomy, Cystectomy, Nephrectomy, Urologic Cancer
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Enrollment: 110
Sponsor: Medtronic - MITG
Summary
The purpose of this study is to collect evidence on the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
Eligibility Criteria
Inclusion Criteria:
* Subject is an acceptable candidate for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
* Adult subjects (age ≥ 22 years) as required by local law
* Subject has been indicated for a radical prostatectomy, radical cystectomy, and/or partial/radical nephrectomy
* Subject is an acceptable candidate for any surgical approach: fully RAS procedure, laparoscopic surgical procedure, or open surgical procedure
* The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form in accordance with the Declaration of Helsinki
Exclusion Criteria:
* Contraindicated for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
* Subject is less than legal age of consent, legally incompetent, or otherwise considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
* Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
* Subject is participating in another clinical investigation at the time of enrollment or has planned participation in another clinical investigation at any time during this study that may influence the results of this study
Source: ClinicalTrials.gov (NCT07901049). StuddyBuddy aggregates publicly available trial information.