Trial Outcomes & Findings for Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO) (NCT NCT05696444)
NCT ID: NCT05696444
Last Updated: 2025-11-25
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
During surgical procedure
Results posted on
2025-11-25
Participant Flow
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.
A total of 144 subjects were consented for enrollment. 7 subjects were discontinued from the study prior to their procedure.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Treatment
STARTED
|
55
|
29
|
53
|
|
Treatment
COMPLETED
|
55
|
28
|
53
|
|
Treatment
NOT COMPLETED
|
0
|
1
|
0
|
|
30 Days
STARTED
|
55
|
28
|
53
|
|
30 Days
COMPLETED
|
53
|
26
|
52
|
|
30 Days
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Treatment
Physician Decision
|
0
|
1
|
0
|
|
30 Days
Death
|
1
|
1
|
0
|
|
30 Days
Missed Visit
|
1
|
1
|
1
|
Baseline Characteristics
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Baseline characteristics by cohort
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy
n=55 Participants
RAS Prostatectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=45 Participants
|
9 Participants
n=12929 Participants
|
30 Participants
n=6349 Participants
|
72 Participants
n=4548 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=45 Participants
|
20 Participants
n=12929 Participants
|
23 Participants
n=6349 Participants
|
65 Participants
n=4548 Participants
|
|
Age, Continuous
|
62.9 Years
STANDARD_DEVIATION 6.70 • n=45 Participants
|
68.9 Years
STANDARD_DEVIATION 9.24 • n=12929 Participants
|
61.2 Years
STANDARD_DEVIATION 10.32 • n=6349 Participants
|
63.5 Years
STANDARD_DEVIATION 9.19 • n=4548 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
20 Participants
n=6349 Participants
|
23 Participants
n=4548 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=45 Participants
|
26 Participants
n=12929 Participants
|
33 Participants
n=6349 Participants
|
114 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
8 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=45 Participants
|
19 Participants
n=12929 Participants
|
36 Participants
n=6349 Participants
|
99 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=45 Participants
|
8 Participants
n=12929 Participants
|
15 Participants
n=6349 Participants
|
30 Participants
n=4548 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · White
|
42 Participants
n=45 Participants
|
20 Participants
n=12929 Participants
|
31 Participants
n=6349 Participants
|
93 Participants
n=4548 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · Black or African American
|
7 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
14 Participants
n=6349 Participants
|
25 Participants
n=4548 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · Asian
|
1 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
5 Participants
n=6349 Participants
|
8 Participants
n=4548 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · Other
|
2 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
3 Participants
n=4548 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · Unknown
|
3 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
6 Participants
n=4548 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · Native American or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=45 Participants
|
29 Participants
n=12929 Participants
|
53 Participants
n=6349 Participants
|
137 Participants
n=4548 Participants
|
PRIMARY outcome
Timeframe: During surgical procedurePopulation: 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.
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.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=136 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
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.
|
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.
|
|---|---|---|---|
|
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
|
134 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 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.
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
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=54 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=28 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=52 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.
|
2 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=55 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=52 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.
|
31 Participants
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: up to 720 minutesPopulation: 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).
Operative time shall be collected through the length of the procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=55 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=28 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=51 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Operative Time (Min)
|
227.8 Minutes
Standard Deviation 54.01
|
357.8 Minutes
Standard Deviation 83.26
|
178.7 Minutes
Standard Deviation 69.52
|
SECONDARY outcome
Timeframe: intraoperativePopulation: Intraoperative Estimated Blood loss, as a safety measure, is reported for all subjects in whom Hugo was utilized during the procedure.
Intraoperative estimated blood loss shall be collected through the length of the procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=55 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).
|
161.5 mL
Standard Deviation 89.34
|
394.7 mL
Standard Deviation 380.29
|
117.5 mL
Standard Deviation 122.45
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Transfusion rate, as a safety measure, is reported for all subjects in whom Hugo was utilized during the procedure.
Transfusion rate shall be collected through 30 days post-procedure
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=55 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Transfusion Rate Through 30 Days.
|
0 Participants
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: intraoperativePopulation: Rate of Device Related Conversions is reported for all subjects in whom Hugo was utilized during the procedure.
Rate of device-related conversions shall be collected through the length of the procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=55 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Rate of Device-related Conversions
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Hospital Length of Stay is reported for all subjects in whom Hugo was utilized during the procedure.
Hospital length of stay (days) shall be collected through 30 days post-procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=55 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Hospital Length of Stay (Days)
|
1.2 Days
Standard Deviation 0.9
|
8.4 Days
Standard Deviation 11.44
|
1.7 Days
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Readmission rate, as a safety measure, is reported for all subjects in whom Hugo was utilized during the procedure.
Readmission rate shall be collected though 30 days post-procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=55 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Readmission Rate (Through 30 Days)
|
2 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Reoperation rate, as a safety measure, is reported for all subjects in whom Hugo was utilized during the procedure.
Reoperation rate shall be collected through 30 days post-procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=55 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Reoperation Rate (Through 30 Days).
|
0 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysMortality rate shall be collected through 30 days post-procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery
n=55 Participants
Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 Participants
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 Participants
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Mortality Rate (Through 30 Days).
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 yearsProgression-free survival rate will be assessed through 5 years in oncologic subjects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDisease-free survival rate will be assessed through 5 years in oncologic subjects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOverall survival rate will be assessed through 5 years in oncologic subjects.
Outcome measures
Outcome data not reported
Adverse Events
Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy
Serious events: 5 serious events
Other events: 19 other events
Deaths: 1 deaths
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
Serious events: 15 serious events
Other events: 7 other events
Deaths: 1 deaths
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
Serious events: 7 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy
n=55 participants at risk
RAS Prostatectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have the RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 participants at risk
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have the RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 participants at risk
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
General disorders
Oedema Peripheral
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
24.1%
7/29 • Number of events 7 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
6.9%
2/29 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
General disorders
Death
|
1.8%
1/55 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Infections and infestations
Sepsis
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
1/55 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
6.9%
2/29 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
6.9%
2/29 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Gastrointestinal Injury
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Post Procedural Urine Leak
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
6.9%
2/29 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Post Procedural Hameorrhage
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Nervous system disorders
Syncope
|
1.8%
1/55 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
13.8%
4/29 • Number of events 4 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
6.9%
2/29 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/55 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Skin and subcutaneous tissue disorders
Umbilical Haematoma
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/55 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Vascular disorders
Lymphocele
|
1.8%
1/55 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/29 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
Other adverse events
| Measure |
Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy
n=55 participants at risk
RAS Prostatectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have the RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy
n=29 participants at risk
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have the RAS surgery using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy
n=53 participants at risk
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.5%
3/55 • Number of events 3 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
6.9%
2/29 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
7.5%
4/53 • Number of events 4 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/55 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
10.3%
3/29 • Number of events 3 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.6%
2/55 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
6.9%
2/29 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
1.9%
1/53 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Renal and urinary disorders
Urinary Incontinence
|
29.1%
16/55 • Number of events 16 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
3.4%
1/29 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/53 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
10.9%
6/55 • Number of events 6 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/26 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
0.00%
0/33 • All Adverse Events were collected from the time of consent through 30 days post procedure.
All participant deaths within the database snapshot were included.
|
Additional Information
Michele Masters, Sr. Clinical Research Program Manager
Medtronic
Phone: 4848948925
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60