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

Part of paid clinical trials in Duarte, California.

Sponsor
Medtronic - MITG
Study ID
NCT05696444
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RAS Prostatectomy — DEVICE
    Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.
  • RAS Cystectomy — DEVICE
    Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
  • RAS Nephrectomy — DEVICE
    Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.

Study Details

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

Key Dates

Start date
Dec 14, 2022
Status verified
Nov 2025
Primary completion
Oct 10, 2024
Completion
Jan 31, 2030

Study Design

Enrollment
144 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Robotic Assisted Surgery (RAS) Urologic Surgery
    Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).

Primary Outcome Measure

Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion [ Time Frame: During surgical procedure ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of ChiagoChicagoIllinois60612-
Mount SinaiNew YorkNew York10029-
Duke Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Swedish Medical CenterSeattleWashington98122-

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By research site
City of Hope· Duarte, CAUniversity of Chiago· Chicago, ILMount Sinai· New York, NYDuke Medical Center· Durham, NCCleveland Clinic· Cleveland, OHSwedish Medical Center· Seattle, WA

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