Clinical trial NCT05696444: Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Official title: A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bladder Cancer
Prostate Cancer
Kidney Cancer
Pelvic Tumor
Interstitial Cystitis
Congenital Abnormalities
End Stage Renal Disease
Renal Tumor
Kidney Injury
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 141
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: A prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic indication will be followed for 30 days post-procedure. Oncologic subjects will be followed annually through 5 years. The study will be conducted in up to 6 investigative sites in the United States of America (USA).

Eligibility criteria: Inclusion Criteria:

1. Adult subjects (age ≥ 22 years) as required by local law
2. Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure
3. Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
4. The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form

Exclusion Criteria:

1. Subjects for which minimally invasive surgery is contraindicated as determined by the Investigator
2. Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
3. 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
4. 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.
5. Female subjects pregnant at the time of the surgical procedure.
6. Subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
7. Subjects who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
8. Subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia

Primary outcomes:
measure: Primary Effectiveness Endpoint - Surgical Success Rate, defined as the procedure not going into conversion
timeFrame: 30 days
measure: Primary Safety Endpoint - Rate of subjects with complications meeting Grade III - Grade V criteria per the Clavien-Dindo Classification System.
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Endpoint - Overall complication rate from first incision through 30 days post-procedure.
timeFrame: 30 days
measure: Secondary Endpoint - Operative Time (min)
timeFrame: up to 720 minutes
measure: Secondary Endpoint - Intraoperative estimated blood loss (mL).
timeFrame: intraoperative
measure: Secondary Endpoint - Transfusion Rate through 30 days.
timeFrame: 30 days
measure: Secondary Endpoint - Rate of device-related conversions
timeFrame: intraoperative
measure: Secondary Endpoint - Hospital length of stay (days)
timeFrame: 30 days
measure: Secondary Endpoint - Readmission rate (through 30 days)
timeFrame: 30 days
measure: Secondary Endpoint - Reoperation rate (through 30 days).
timeFrame: 30 days
measure: Secondary Endpoint - Mortality rate (through 30 days).
timeFrame: 30 days
measure: Secondary Endpoint - Rate of Device deficiencies (number).
timeFrame: 30 days
measure: Secondary Endpoint - Overall survival rate
timeFrame: 5 years
measure: Secondary Endpoint - Progression-free survival
timeFrame: 5 years
measure: Secondary Endpoint - Disease-free Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Chicago
country: United States
facility: University of Chiago
state: Illinois
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Duke Medical Center
name: Michael Abern, MD
role: STUDY_CHAIR
References: