Bladder Cancer, Congenital Abnormalities, End Stage Renal Disease, Interstitial Cystitis, Kidney Cancer, Kidney Injury, Pelvic Tumor, Prostate Cancer, Renal Tumor
Conditions
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).
Interventions
DEVICERAS Prostatectomy
Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.
DEVICERAS Cystectomy
Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
DEVICERAS Nephrectomy
Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion | During surgical procedure | The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery. |
| Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System. | 30 days | Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure. Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure. | 30 days | Complication rate: Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure. |
| Secondary Endpoint - Operative Time (Min) | up to 720 minutes | Operative time shall be collected through the length of the procedure. |
| Secondary Endpoint - Intraoperative Estimated Blood Loss (mL). | intraoperative | Intraoperative estimated blood loss shall be collected through the length of the procedure. |
| Secondary Endpoint - Transfusion Rate Through 30 Days. | 30 days | Transfusion rate shall be collected through 30 days post-procedure |
| Secondary Endpoint - Rate of Device-related Conversions | intraoperative | Rate of device-related conversions shall be collected through the length of the procedure. |
| Secondary Endpoint - Hospital Length of Stay (Days) | 30 days | Hospital length of stay (days) shall be collected through 30 days post-procedure. |
| Secondary Endpoint - Readmission Rate (Through 30 Days) | 30 days | Readmission rate shall be collected though 30 days post-procedure. |
| Secondary Endpoint - Reoperation Rate (Through 30 Days). | 30 days | Reoperation rate shall be collected through 30 days post-procedure. |
| Secondary Endpoint - Mortality Rate (Through 30 Days). | 30 days | Mortality rate shall be collected through 30 days post-procedure. |
| Secondary Endpoint - Progression-free Survival | 5 years | Progression-free survival rate will be assessed through 5 years in oncologic subjects. |
| Secondary Endpoint - Disease-free Survival | 5 years | Disease-free survival rate will be assessed through 5 years in oncologic subjects. |
| Secondary Endpoint - Overall Survival | 5 years | Overall survival rate will be assessed through 5 years in oncologic subjects. |
Countries
United States
Participant flow
Recruitment details
There was no minimum enrollment requirement at each site; individual sites were not allowed to enroll more than 30% of the total study population. 137 subjects from 6 US sites contributed to the study cohort.
Pre-assignment details
A total of 144 subjects were consented for enrollment. 7 subjects were discontinued from the study prior to their procedure.
Participants by arm
| Arm | Count |
|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy RAS Prostatectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system. | 55 |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system. | 29 |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system. | 53 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 30 Days | Death | 1 | 1 | 0 |
| 30 Days | Missed Visit | 1 | 1 | 1 |
| Treatment | Physician Decision | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 20 Participants | 22 Participants | 65 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 9 Participants | 33 Participants | 72 Participants |
| Age, Continuous | 61.2 Years STANDARD_DEVIATION 10.32 | 68.9 Years STANDARD_DEVIATION 9.24 | 62.9 Years STANDARD_DEVIATION 6.7 | 63.5 Years STANDARD_DEVIATION 9.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 19 Participants | 44 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 8 Participants | 7 Participants | 30 Participants |
| Race/Ethnicity, Customized Race, Ethnicity American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, Ethnicity Asian | 5 Participants | 2 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Race, Ethnicity Black or African American | 14 Participants | 4 Participants | 7 Participants | 25 Participants |
| Race/Ethnicity, Customized Race, Ethnicity Native American or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race, Ethnicity Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, Ethnicity Other | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race, Ethnicity Unknown | 1 Participants | 2 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Race, Ethnicity White | 31 Participants | 20 Participants | 42 Participants | 93 Participants |
| Region of Enrollment United States | 53 Participants | 29 Participants | 55 Participants | 137 Participants |
| Sex: Female, Male Female | 20 Participants | 3 Participants | 0 Participants | 23 Participants |
| Sex: Female, Male Male | 33 Participants | 26 Participants | 55 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 55 | 1 / 29 | 0 / 53 |
| other Total, other adverse events | 19 / 55 | 7 / 29 | 6 / 53 |
| serious Total, serious adverse events | 5 / 55 | 15 / 29 | 7 / 53 |
Outcome results
Primary
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery.
Time frame: During surgical procedure
Population: One subject in the cystectomy cohort who met the criteria to be included in the Full Analysis set (FAS), as they received their first incision with intent of using Hugo, was excluded from the analysis as their procedure was aborted after an hour of exploration due to an advanced disease state. Data from the three RAS Urologic Surgery cohorts: Prostatectomy, Cystectomy, \& Nephrectomy were combined for analysis per pre-specified analysis plan.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion | 134 Participants |
p-value: <0.0001Exact test
Primary
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.
Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure. Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient
Time frame: 30 days
Population: Three subjects (1 prostatectomy, 1 cystectomy, 1 nephrectomy) had a missed 30-day follow-up visit.~Subjects must have met one of the following conditions to be included:~* They experienced a documented major complication within 30 days of the index procedure, regardless of whether the 30-day visit occurred. OR~* They completed their 30-day visit, confirming that no major complication occurred.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System. | 2 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System. | 5 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System. | 1 Participants |
p-value: 0.0006Exact test
Comparison: Test was calculated using an exact test against a null value of 0.45p-value: 0.0025Exact test
Comparison: Test was calculated using an exact test against a null value of 0.2p-value: 0.0001Exact test
Secondary
Secondary Endpoint - Disease-free Survival
Disease-free survival rate will be assessed through 5 years in oncologic subjects.
Time frame: 5 years
Secondary
Secondary Endpoint - Hospital Length of Stay (Days)
Hospital length of stay (days) shall be collected through 30 days post-procedure.
Time frame: 30 days
Population: Hospital Length of Stay is reported for all subjects in whom Hugo was utilized during the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Secondary Endpoint - Hospital Length of Stay (Days) | 1.2 Days | Standard Deviation 0.9 |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Secondary Endpoint - Hospital Length of Stay (Days) | 8.4 Days | Standard Deviation 11.44 |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Secondary Endpoint - Hospital Length of Stay (Days) | 1.7 Days | Standard Deviation 1.53 |
Secondary
Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).
Intraoperative estimated blood loss shall be collected through the length of the procedure.
Time frame: intraoperative
Population: Intraoperative Estimated Blood loss, as a safety measure, is reported for all subjects in whom Hugo was utilized during the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Secondary Endpoint - Intraoperative Estimated Blood Loss (mL). | 161.5 mL | Standard Deviation 89.34 |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Secondary Endpoint - Intraoperative Estimated Blood Loss (mL). | 394.7 mL | Standard Deviation 380.29 |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Secondary Endpoint - Intraoperative Estimated Blood Loss (mL). | 117.5 mL | Standard Deviation 122.45 |
Secondary
Secondary Endpoint - Mortality Rate (Through 30 Days).
Mortality rate shall be collected through 30 days post-procedure.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Secondary Endpoint - Mortality Rate (Through 30 Days). | 1 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Secondary Endpoint - Mortality Rate (Through 30 Days). | 1 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Secondary Endpoint - Mortality Rate (Through 30 Days). | 0 Participants |
Secondary
Secondary Endpoint - Operative Time (Min)
Operative time shall be collected through the length of the procedure.
Time frame: up to 720 minutes
Population: Operative time, an efficacy measure, is reported only for subjects whose procedures were completed as planned using the Hugo system. This measure excludes aborted cases (n=1 cystectomy) and converted cases (n=2 nephrectomies).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Secondary Endpoint - Operative Time (Min) | 227.8 Minutes | Standard Deviation 54.01 |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Secondary Endpoint - Operative Time (Min) | 357.8 Minutes | Standard Deviation 83.26 |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Secondary Endpoint - Operative Time (Min) | 178.7 Minutes | Standard Deviation 69.52 |
Secondary
Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.
Complication rate: Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.
Time frame: 30 days
Population: Subjects must have met one of the following conditions to be included:~* They experienced any complication within 30 days of the index procedure, regardless of whether the 30-day visit occurred. OR~* They completed their 30-day visit, confirming that no complications occurred.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure. | 31 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure. | 24 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure. | 24 Participants |
Secondary
Secondary Endpoint - Overall Survival
Overall survival rate will be assessed through 5 years in oncologic subjects.
Time frame: 5 years
Secondary
Secondary Endpoint - Progression-free Survival
Progression-free survival rate will be assessed through 5 years in oncologic subjects.
Time frame: 5 years
Secondary
Secondary Endpoint - Rate of Device-related Conversions
Rate of device-related conversions shall be collected through the length of the procedure.
Time frame: intraoperative
Population: Rate of Device Related Conversions is reported for all subjects in whom Hugo was utilized during the procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Secondary Endpoint - Rate of Device-related Conversions | 0 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Secondary Endpoint - Rate of Device-related Conversions | 0 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Secondary Endpoint - Rate of Device-related Conversions | 1 Participants |
Secondary
Secondary Endpoint - Readmission Rate (Through 30 Days)
Readmission rate shall be collected though 30 days post-procedure.
Time frame: 30 days
Population: Readmission rate, as a safety measure, is reported for all subjects in whom Hugo was utilized during the procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Secondary Endpoint - Readmission Rate (Through 30 Days) | 2 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Secondary Endpoint - Readmission Rate (Through 30 Days) | 6 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Secondary Endpoint - Readmission Rate (Through 30 Days) | 4 Participants |
Secondary
Secondary Endpoint - Reoperation Rate (Through 30 Days).
Reoperation rate shall be collected through 30 days post-procedure.
Time frame: 30 days
Population: Reoperation rate, as a safety measure, is reported for all subjects in whom Hugo was utilized during the procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Secondary Endpoint - Reoperation Rate (Through 30 Days). | 0 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Secondary Endpoint - Reoperation Rate (Through 30 Days). | 3 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Secondary Endpoint - Reoperation Rate (Through 30 Days). | 1 Participants |
Secondary
Secondary Endpoint - Transfusion Rate Through 30 Days.
Transfusion rate shall be collected through 30 days post-procedure
Time frame: 30 days
Population: Transfusion rate, as a safety measure, is reported for all subjects in whom Hugo was utilized during the procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Surgery (RAS) Urologic Surgery | Secondary Endpoint - Transfusion Rate Through 30 Days. | 0 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy | Secondary Endpoint - Transfusion Rate Through 30 Days. | 9 Participants |
| Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy | Secondary Endpoint - Transfusion Rate Through 30 Days. | 1 Participants |