Trial Outcomes & Findings for Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair) (NCT NCT06445504)
NCT ID: NCT06445504
Last Updated: 2026-05-04
Results Overview
The primary effectiveness endpoint is rate of subjects who have surgical success, with surgical success defined as the procedure not going into conversion. Conversion is defined as the switch from the robotic-assisted approach using the Hugo™ RAS system to laparoscopic, open surgery, or use of an alternative robotic-assisted system.
ACTIVE_NOT_RECRUITING
NA
206 participants
During surgical procedure, over an average of 81 minutes
2026-05-04
Participant Flow
There was no minimum enrollment requirement at each site. A single study site was allowed to treat no more than 30% of the total population. 193 subjects from 7 US sites contributed to the study.
A total of 206 subjects were consented for enrollment. Thirteen subjects were discontinued from the study prior to the procedure.
Participant milestones
| Measure |
Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
|---|---|---|
|
Treatment
STARTED
|
97
|
96
|
|
Treatment
Inguinal Unilateral Hernia Repair Procedure
|
76
|
0
|
|
Treatment
Inguinal Bilateral Hernia Repair Procedure
|
21
|
0
|
|
Treatment
COMPLETED
|
97
|
96
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
|
30 Days
STARTED
|
97
|
96
|
|
30 Days
COMPLETED
|
90
|
92
|
|
30 Days
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
|---|---|---|
|
30 Days
Missed Visit
|
5
|
4
|
|
30 Days
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
Baseline characteristics by cohort
| Measure |
Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair
n=97 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=96 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 Years
STANDARD_DEVIATION 13.67 • n=54 Participants
|
55.4 Years
STANDARD_DEVIATION 13.23 • n=60 Participants
|
57.4 Years
STANDARD_DEVIATION 13.56 • n=114 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=54 Participants
|
33 Participants
n=60 Participants
|
41 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=54 Participants
|
63 Participants
n=60 Participants
|
152 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=54 Participants
|
89 Participants
n=60 Participants
|
182 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
84 Participants
n=54 Participants
|
77 Participants
n=60 Participants
|
161 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=54 Participants
|
15 Participants
n=60 Participants
|
21 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Multiracial/multicultural
|
2 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
97 Participants
n=54 Participants
|
96 Participants
n=60 Participants
|
193 Participants
n=114 Participants
|
|
Height
|
176.7 cm
STANDARD_DEVIATION 9.15 • n=54 Participants
|
173.5 cm
STANDARD_DEVIATION 8.69 • n=60 Participants
|
175.1 cm
STANDARD_DEVIATION 9.04 • n=114 Participants
|
|
Weight
|
82.7 kg
STANDARD_DEVIATION 14.52 • n=54 Participants
|
92.3 kg
STANDARD_DEVIATION 18.75 • n=60 Participants
|
87.5 kg
STANDARD_DEVIATION 17.39 • n=114 Participants
|
|
BMI
|
26.4 kg/m2
STANDARD_DEVIATION 3.37 • n=54 Participants
|
30.5 kg/m2
STANDARD_DEVIATION 5.11 • n=60 Participants
|
28.4 kg/m2
STANDARD_DEVIATION 4.79 • n=114 Participants
|
PRIMARY outcome
Timeframe: During surgical procedure, over an average of 81 minutesPopulation: Enrolled subjects in whom the Hugo™ RAS procedure is begun, defined as the first skin incision. This is the full analysis set (FAS).
The primary effectiveness endpoint is rate of subjects who have surgical success, with surgical success defined as the procedure not going into conversion. Conversion is defined as the switch from the robotic-assisted approach using the Hugo™ RAS system to laparoscopic, open surgery, or use of an alternative robotic-assisted system.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Hernia Repair
n=193 Participants
Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) and for primary or incisional ventral hernia(s) using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Primary Effectiveness Endpoint - Rate of Subjects With Surgical Success
|
193 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: 30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit \<23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).
The primary safety endpoint is the overall rate of subjects with one or more procedure- and/or device-related surgical site events (SSEs), from the first incision through 30 days post-procedure. SSE is defined as the following complications: * Surgical-site occurrence (SSO): Bleeding, Hemorrhage: Requiring transfusion; Bowel Injury; Bowel Obstruction; Cellulitis; Epigastric Vessel Injury; Symptomatic Hematoma: Requiring procedural intervention; Symptomatic Seroma: Requiring procedural intervention; Symptomatic Edema: Requiring procedural intervention * Surgical-site infection (SSI): Infection occurring where the surgery took place, including superficial, deep, and organ space infections (standardized definition developed by the CDC)
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Hernia Repair
n=92 Participants
Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) and for primary or incisional ventral hernia(s) using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=94 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Primary Safety Endpoint - Rate of Subjects With Surgical Site Event
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: This is the same analysis population used for the Primary Safety Endpoint; however, two inguinal hernia subjects who were excluded from most 30-day endpoints for having no follow-up visits after the procedure had a non-major complication within 30-days, so were included in the denominator for this analysis.
Overall rate of subjects with one or more procedure- and/or device-related complications (Clavien-Dindo Grade I or higher), from the time of the first incision through 30 days post-procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Hernia Repair
n=94 Participants
Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) and for primary or incisional ventral hernia(s) using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=94 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Rate of Subjects With Complications
|
33 Participants
|
40 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: 30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit \<23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).
Overall rate of subjects with one or more major procedure- and/or device-related complications (Clavien-Dindo Grade III or higher), from the time of the first incision through 30 days post-procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Hernia Repair
n=92 Participants
Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) and for primary or incisional ventral hernia(s) using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=94 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Rate of Subjects With Major Complications
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: IntraoperativePopulation: Enrolled subjects in whom the Hugo™ RAS procedure is begun, defined as the first skin incision. This is the full analysis set (FAS).
Minutes from skin incision to skin closure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Hernia Repair
n=76 Participants
Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) and for primary or incisional ventral hernia(s) using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=21 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=96 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Operative Time
|
72 Minutes
Standard Deviation 31.3
|
121 Minutes
Standard Deviation 43.4
|
79 Minutes
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: 30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit \<23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).
Admission for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia from the day after the index procedure to 30 days post-procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Hernia Repair
n=92 Participants
Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) and for primary or incisional ventral hernia(s) using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=94 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Rate of Subjects With Readmission
|
1 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: 30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit \<23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).
Operation for a direct consequence or complication associated with the treated hernia or with the surgical procedure to treat the hernia from the day after the index procedure to 30 days post-procedure.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Hernia Repair
n=92 Participants
Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) and for primary or incisional ventral hernia(s) using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=94 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Rate of Subjects With Reoperation
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: 30-day Analyzable Subjects: This is the subject cohort used for objectives related to results through 30-days. Inguinal Subjects: 5 Full Analysis Set (FAS) subjects excluded for: 1) Missing the 30-day and 3-month visits (n=2); 2) discontinuing prior to 30 days (n=2); 3) having a 30-day visit \<23 days after the procedure and missing the 3-month visit (n=1). Ventral Subjects: 2 FAS subject excluded for missing the 30-day and 3-month visits (n=2).
Clinical hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge within 7 cm of the original repair, exacerbated by a Valsalva maneuver during physical examination by a study investigator.
Outcome measures
| Measure |
Robotic Assisted Surgery (RAS) Hernia Repair
n=92 Participants
Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) and for primary or incisional ventral hernia(s) using the Medtronic Hugo RAS system.
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=94 Participants
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system.
|
|---|---|---|---|
|
Secondary Endpoint - Rate of Subjects With Recurrence
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 YearsClinical hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge within 7 cm of the original repair, exacerbated by a Valsalva maneuver during physical examination by a study investigator. Suspected hernia recurrence(s) reported by a subject, but not confirmed by an investigator, will not be considered as a clinical hernia recurrence for this endpoint, but will be reported separately as a subject-reported recurrence.
Outcome measures
Outcome data not reported
Adverse Events
Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
Serious adverse events
| Measure |
Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair
n=97 participants at risk
Subjects indicated for Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=96 participants at risk
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
|---|---|---|
|
Infections and infestations
Incision Site Abscess
|
0.00%
0/97 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
1.0%
1/96 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/97 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
1.0%
1/96 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Eye disorders
Visual Impairment
|
1.0%
1/97 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
0.00%
0/96 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Vascular disorders
Haematoma
|
0.00%
0/97 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
1.0%
1/96 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/97 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
1.0%
1/96 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/97 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
1.0%
1/96 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Renal and urinary disorders
Urinary Retention
|
1.0%
1/97 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
0.00%
0/96 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Seroma
|
1.0%
1/97 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
0.00%
0/96 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
Other adverse events
| Measure |
Robotic Assisted Surgery (RAS) - Inguinal Hernia Repair
n=97 participants at risk
Subjects indicated for Robotic Assisted Surgery (RAS) for inguinal (unilateral or bilateral) hernia(s) will have RAS using the Medtronic Hugo RAS system
|
Robotic Assisted Surgery (RAS) - Ventral Hernia Repair
n=96 participants at risk
Subjects indicated for Robotic Assisted Surgery (RAS) for primary or incisional ventral hernia(s) will have RAS using the Medtronic Hugo RAS system
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
12.4%
12/97 • Number of events 12 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
13.5%
13/96 • Number of events 13 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Gastrointestinal disorders
Constipation
|
4.1%
4/97 • Number of events 4 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
0.00%
0/96 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
4.1%
4/97 • Number of events 5 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
0.00%
0/96 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
3.1%
3/97 • Number of events 3 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
5.2%
5/96 • Number of events 5 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Seroma
|
3.1%
3/97 • Number of events 4 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
2.1%
2/96 • Number of events 2 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
1.0%
1/97 • Number of events 1 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
4.2%
4/96 • Number of events 4 • All Adverse Events were collected from the time of consent through 30 days post procedure.
Deaths were to be collected throughout a subject's participation. All participant adverse events within the database snapshot were included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER