Trial Outcomes & Findings for A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair. (NCT NCT01961687)
NCT ID: NCT01961687
Last Updated: 2021-01-26
Results Overview
Hernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
60 Months
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
Phasix Mesh Group
Patients requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
|
|---|---|
|
Overall Study
STARTED
|
121
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
Phasix Mesh Group
Patients requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
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|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
Re-operation
|
17
|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Moved to area without study site
|
2
|
|
Overall Study
Sponsor decision
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Unable to meet follow-up requirements
|
1
|
Baseline Characteristics
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
Baseline characteristics by cohort
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
121 participants
n=5 Participants
|
|
BMI
|
32.24 kg/m^2
STANDARD_DEVIATION 4.52 • n=5 Participants
|
PRIMARY outcome
Timeframe: 60 MonthsHernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
Outcome measures
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
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|---|---|
|
Hernia Recurrence Rate
|
20 Participants
|
PRIMARY outcome
Timeframe: 60 MonthsInfections at the surgical site will be assessed by physical examination at each study visit through 60 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial and deep surgical site infections
Outcome measures
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
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|---|---|
|
Surgical Site Infections
|
11 Participants
|
SECONDARY outcome
Timeframe: 60 MonthsMean change in self-reported pain measured on a Visual Analog Scale between Baseline and 60-month follow up. Scores are measured on a scale from 0.0 to 10.0 centimeters and marked on a line by the subject; lower values correspond with low pain perception. The outcome measure is presented as the mean of the absolute difference between the pain perception at Baseline and the pain perception at 60-month follow up. A negative score means a decrease in pain perception.
Outcome measures
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
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|---|---|
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Pain Visual Analog Scale
|
-3.16 cm
Standard Deviation 3.35
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SECONDARY outcome
Timeframe: 60 MonthsIncidence of device related adverse events: number of subjects with one or more possibly or definitely device related adverse events. The term "incidence" is an error and is reported here as the rate of device related adverse events.
Outcome measures
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
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|---|---|
|
Device Related Adverse Events
|
19 Participants
|
SECONDARY outcome
Timeframe: 60 MonthsRate of re-operation due to the index hernia repair; the proportion of subjects with post-procedure re-operation due do the index hernia repair.
Outcome measures
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
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|---|---|
|
Rate of Re-operation Due to the Index Hernia Repair
|
18 Participants
|
SECONDARY outcome
Timeframe: 60 MonthsPopulation: The number of participants noted at each time point differ from the overall number (121) due to only having the eligible questionnaires being analyzed. The number of eligible questionnaires range from 52 to 111.
Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is a summation of scores across the domains. Therefore, the Total CCS Score ranges from 0-115 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, 12-Month follow-up, 18-Month follow up, at 24-Month follow-up, 36-Month follow-up, 48-Month follow-up, and 60-Month follow-up are reported. The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results.
Outcome measures
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
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|---|---|
|
Carolinas Comfort Scale® (CCS)
Total CCS Score at 1 Month
|
31.2 Score on a scale
Standard Error 23.3
|
|
Carolinas Comfort Scale® (CCS)
Total CCS Score at 3 Month
|
18.5 Score on a scale
Standard Error 20.9
|
|
Carolinas Comfort Scale® (CCS)
Total CCS Score at 6 Month
|
14.1 Score on a scale
Standard Error 20.7
|
|
Carolinas Comfort Scale® (CCS)
Total CCS Score at 12 Month
|
11.6 Score on a scale
Standard Error 21.1
|
|
Carolinas Comfort Scale® (CCS)
Total CCS Score at 18 Month
|
8.4 Score on a scale
Standard Error 16.6
|
|
Carolinas Comfort Scale® (CCS)
Total CCS Score at 24 Month
|
10.5 Score on a scale
Standard Error 20.7
|
|
Carolinas Comfort Scale® (CCS)
Total CCS Score at 36 Month
|
9.8 Score on a scale
Standard Error 21.4
|
|
Carolinas Comfort Scale® (CCS)
Total CCS Score at 48 Month
|
9.8 Score on a scale
Standard Error 21.4
|
|
Carolinas Comfort Scale® (CCS)
Total CCS Score at 60 Month
|
4.9 Score on a scale
Standard Error 14.2
|
SECONDARY outcome
Timeframe: 60 MonthsThe Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
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|---|---|
|
SF-12 Questionnaire
PCS - Month 1
|
-2.700 Absolute Change from Baseline
Standard Deviation 9.999
|
|
SF-12 Questionnaire
PCS - Month 3
|
5.374 Absolute Change from Baseline
Standard Deviation 8.951
|
|
SF-12 Questionnaire
PCS - Month 6
|
6.943 Absolute Change from Baseline
Standard Deviation 9.352
|
|
SF-12 Questionnaire
PCS - Month 12
|
6.868 Absolute Change from Baseline
Standard Deviation 10.986
|
|
SF-12 Questionnaire
PCS - Month 18
|
7.589 Absolute Change from Baseline
Standard Deviation 11.416
|
|
SF-12 Questionnaire
PCS - Month 24
|
6.206 Absolute Change from Baseline
Standard Deviation 10.442
|
|
SF-12 Questionnaire
PCS - Month 36
|
7.101 Absolute Change from Baseline
Standard Deviation 9.652
|
|
SF-12 Questionnaire
PCS - Month 48
|
7.206 Absolute Change from Baseline
Standard Deviation 12.045
|
|
SF-12 Questionnaire
PCS - Month 60
|
7.374 Absolute Change from Baseline
Standard Deviation 9.997
|
|
SF-12 Questionnaire
MCS - Month 1
|
0.546 Absolute Change from Baseline
Standard Deviation 10.304
|
|
SF-12 Questionnaire
MCS - Month 3
|
3.287 Absolute Change from Baseline
Standard Deviation 9.822
|
|
SF-12 Questionnaire
MCS - Month 6
|
3.311 Absolute Change from Baseline
Standard Deviation 9.911
|
|
SF-12 Questionnaire
MCS - Month 12
|
2.124 Absolute Change from Baseline
Standard Deviation 9.648
|
|
SF-12 Questionnaire
MCS - Month 18
|
2.015 Absolute Change from Baseline
Standard Deviation 11.183
|
|
SF-12 Questionnaire
MCS - Month 24
|
2.769 Absolute Change from Baseline
Standard Deviation 9.841
|
|
SF-12 Questionnaire
MCS - Month 36
|
-0.239 Absolute Change from Baseline
Standard Deviation 11.142
|
|
SF-12 Questionnaire
MCS - Month 48
|
2.393 Absolute Change from Baseline
Standard Deviation 10.240
|
|
SF-12 Questionnaire
MCS - Month 60
|
3.248 Absolute Change from Baseline
Standard Deviation 10.782
|
SECONDARY outcome
Timeframe: 1 daySurgical procedure time as measured from incision to closure (skin to skin)
Outcome measures
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
|
|---|---|
|
Surgical Procedure Time as Measured From Incision to Closure
|
168 Minutes
Interval 34.0 to 441.0
|
SECONDARY outcome
Timeframe: 35 daysTime in days from hospital admission to discharge
Outcome measures
| Measure |
Phasix Mesh
n=121 Participants
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
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|---|---|
|
Length of Hospital Stay
|
4 Days
Interval 1.0 to 35.0
|
Adverse Events
Phasix Mesh
Serious events: 49 serious events
Other events: 104 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Phasix Mesh
n=121 participants at risk
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Cardiac disorders
Cardio-respiratory Arrest
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Cardiac disorders
Right Ventricular Failure
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Abdominal Wall Disorder
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Colitis
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Colonic Pseudo-obstruction
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Ileus
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
4.1%
5/121 • Number of events 8 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
General disorders
Death
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
General disorders
Generalized Oedema
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
General disorders
Pyrexia
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Infections and infestations
Abdominal Abscess
|
0.83%
1/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Infections and infestations
Clostidium Deficile Infection
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Infections and infestations
Pneumonia
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Infections and infestations
Post-operative Wound Infection
|
4.1%
5/121 • Number of events 5 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Infections and infestations
Sepsis
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Infections and infestations
Septic Shock
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Cardiac Valve Replacement Complication
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Incision Site Erythema
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
9.9%
12/121 • Number of events 12 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Incisional Hernia, Obstructive
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Seroma
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Skin Flap Necrosis
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Ureteric Injury
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle Necrosis
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pseudomyxoma Peritonei
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Nervous system disorders
Embolic Cerebral Infarction
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Nervous system disorders
Encephalopathy
|
1.7%
2/121 • Number of events 3 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Nervous system disorders
Hemiparesis
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Nervous system disorders
Hemiplegia
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Nervous system disorders
Neuralgia
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Nervous system disorders
Serotonin Syndrome
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.7%
2/121 • Number of events 2 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Reproductive system and breast disorders
Adnexa Uteri Cyst
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.7%
2/121 • Number of events 3 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.5%
3/121 • Number of events 3 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.5%
3/121 • Number of events 3 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive Pulmonary Disease
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Vascular disorders
Aortic Aneurysm
|
1.7%
2/121 • Number of events 3 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Vascular disorders
Hypertension
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Vascular disorders
Intra-abdominal Haematoma
|
0.83%
1/121 • Number of events 1 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
Other adverse events
| Measure |
Phasix Mesh
n=121 participants at risk
Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
21.5%
26/121 • Number of events 30 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Constipation
|
5.8%
7/121 • Number of events 8 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
7/121 • Number of events 7 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Ileus
|
6.6%
8/121 • Number of events 8 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Nausea
|
11.6%
14/121 • Number of events 15 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
7/121 • Number of events 8 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Infections and infestations
Postoperative Wound Infection
|
5.0%
6/121 • Number of events 6 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
15.7%
19/121 • Number of events 20 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
9.1%
11/121 • Number of events 12 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
11.6%
14/121 • Number of events 14 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Injury, poisoning and procedural complications
Seroma
|
9.1%
11/121 • Number of events 13 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
|
|
Renal and urinary disorders
Urinary Retention
|
5.0%
6/121 • Number of events 7 • 60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
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Additional Information
Dawn Heimer / Sr. Director Medical Affairs
Becton Dickinson
Phone: 401-479-1253
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place