Ventral Hernia
Conditions
Brief summary
A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)
Detailed description
A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months) 125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)
Interventions
DEVICEParietene DS Composite Mesh
All subjects enrolled will receive the Parietene DS Composite Mesh
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
All subjects enrolled will receive the Parietene DS Composite Mesh
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Preoperative Inclusion Criteria 1. Subject has provided informed consent 2. Subject is ≥18 years of age (at the time of consent) 3. Subject is undergoing elective ventral hernia repair (primary or incisional) with intraperitoneal mesh placement
Exclusion criteria
* Preoperative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair | 12 months post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. | operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery |
| Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair | 1 month, 3 months, and 24 months post-surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parietene DS Composite Mesh Patients treated with Parietene DS Composite Mesh
Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh | 125 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Screen Failures During Surgery | 6 |
| Overall Study | Screen Failures Pre-Operatively | 4 |
| Overall Study | Unable to gather information from subject due to age and limited abilities | 1 |
| Overall Study | Withdrawal by Subject | 2 |
| Overall Study | Withdrawn Prior to Surgery | 10 |
Baseline characteristics
| Characteristic | Parietene DS Composite Mesh |
|---|---|
| Age, Continuous Overall | 58.0 years STANDARD_DEVIATION 12.31 |
| BMI, kg/m^2 | 33.2 kg/m^2 STANDARD_DEVIATION 4.82 |
| Ethnicity Asian | 1 Participants |
| Ethnicity Black or African American | 22 Participants |
| Ethnicity Latino/Hispanic | 2 Participants |
| Ethnicity Middle Eastern | 1 Participants |
| Ethnicity Patient Does Not Want to Disclose | 1 Participants |
| Ethnicity White | 98 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height, cm | 172.5 centimeters STANDARD_DEVIATION 11.15 |
| Pregnancy Test Performed Pregnancy Test at Operative Visit Pregnancy Test Administered: No | 22 Participants |
| Pregnancy Test Performed Pregnancy Test at Operative Visit Pregnancy Test Administered: Yes | 5 Participants |
| Pregnancy Test Performed Pregnancy Test at Screening Visit Pregnancy Test Administered: No | 41 Participants |
| Pregnancy Test Performed Pregnancy Test at Screening Visit Pregnancy Test Administered: Yes | 10 Participants |
| Region of Enrollment United States | 125 participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 74 Participants |
| Weight, kg | 98.4 kilograms STANDARD_DEVIATION 15.96 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 125 |
| other Total, other adverse events | 20 / 125 |
| serious Total, serious adverse events | 29 / 125 |
Outcome results
Primary
Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
Time frame: 12 months post surgery
Population: Hernia recurrence rate at 12M changed from what was previously reported, 4 (3.5%) due to data imputed for hernia recurrence. It was assumed subjects who missed the 12M visit and had no recurrence at 24M also had no recurrence at 12M, as hernias cannot appear and then disappear over time without treatment. There were 5 subjects excluded from the primary endpoint analysis due to not completing the 12M/24M visits and therefore, unable to determine if a recurrence occurred in these subjects.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parietene DS Composite Mesh | Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair | Subjects With Hernia Recurrence at 12-Months | 4 Participants |
| Parietene DS Composite Mesh | Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair | Subjects Without Hernia Recurrence at 12-Months | 116 Participants |
Comparison: Number of participants with hernia recurrence within 12 months following Parietene™ DS Composite Mesh use in ventral hernia repair95% CI: [1, 8.5]
Secondary
Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair.
Time frame: operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parietene DS Composite Mesh | Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. | Number of participants with incidence of ADEs Intra-Operatively | 0 number of participants with ADEs |
| Parietene DS Composite Mesh | Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. | Number of participants with incidence of ADEs at Discharge | 14 number of participants with ADEs |
| Parietene DS Composite Mesh | Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. | Number of participants with incidence of ADEs within 1 Month | 31 number of participants with ADEs |
| Parietene DS Composite Mesh | Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. | Number of participants with incidence of ADEs within 3 Months | 34 number of participants with ADEs |
| Parietene DS Composite Mesh | Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. | Number of participants with incidence of ADEs within 12 Months | 40 number of participants with ADEs |
| Parietene DS Composite Mesh | Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. | Number of participants with incidence of ADEs within 24 Months | 42 number of participants with ADEs |
Secondary
Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
Time frame: 1 month, 3 months, and 24 months post-surgery
Population: The overall number of participants analyzed may vary at different follow-up time points due to some assessments not being completed, which are required for inclusion in the analysis. At Baseline and Procedure there were 125 patients treated; each follow-up visit was missing some of those treated patients. Pre-specified full analysis set was inclusive of patients that missed follow-up. Subjects were not considered lost to follow-up until the 24M follow-up period was completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parietene DS Composite Mesh | Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair | Participants with hernia recurrence within 3 months | 0 Participants |
| Parietene DS Composite Mesh | Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair | Participants with hernia recurrence within 24 months | 4 Participants |
| Parietene DS Composite Mesh | Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair | Participants with hernia recurrence within 1 month | 0 Participants |
95% CI: [0, 2.9]
95% CI: [0, 3]
95% CI: [1.2, 9.6]