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CompletedNCT03495154PPDSUpdated Apr 23, 2024Results posted

Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair

An interventional study of Parietene DS Composite Mesh in Ventral Hernia, sponsored by Medtronic - MITG. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Medtronic - MITG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)

Read the 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)

02

Conditions studied

  • Ventral Hernia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Preoperative Exclusion Criteria

    1. BMI > 45 kg/m2
    2. Subject is undergoing emergency surgery
    3. Subject is pregnant or planning to become pregnant during study participation period
    4. Subject is unable or unwilling to comply with the study requirements or follow-up schedule
    5. Subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
    6. The subject has participated in another investigational drug or device research study within 30 days of enrollment
    7. Subject has a parastomal hernia

  • Intra-operative Exclusion Criteria

    1. Subject's hernia repair is in a contaminated or infected site (CDC wound class 2-4) as assessed by the Investigator(s)
    2. Subject is undergoing "bridging" repair technique with the mesh placed in an "inlay" position
    3. Surgeon is unable to completely remove existing mesh from prior surgery
    4. Surgeon overlays 2 meshes
    5. Subject receives any mesh other than Parietene™ DS composite mesh
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
145 participants (actual)

Study arms

  • Experimental
    Parietene DS Composite Mesh

    Patients treated with Parietene DS Composite Mesh

    Device: Parietene DS Composite Mesh

Interventions

  • DeviceParietene DS Composite Mesh

    All subjects enrolled will receive the Parietene DS Composite Mesh

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

06

Results

Posted Nov 17, 2022
Limitations and caveats
There were no limitations or caveats in this study.

Participant flow

Participant flow — Overall Study
MilestoneParietene DS Composite Mesh
Started145
Full analysis set125
Completed104
Not completed41
Withdrew: Screen failures pre-operatively4
Withdrew: Withdrawn prior to surgery10
Withdrew: Screen failures during surgery6
Withdrew: Death2
Withdrew: Lost to follow-up16
Withdrew: Withdrawal by subject2
Withdrew: Unable to gather information from subject due to age and limited abilities1

Outcome measures

PrimaryNumber of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
Time frame:
12 months post surgery
Reported as:
Count of participants · Participants
Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
ParticipantsParietene DS Composite Mesh
Subjects With Hernia Recurrence at 12-Months4
Subjects Without Hernia Recurrence at 12-Months116
Statistical analysis
  • Parietene DS Composite Mesh · Percentage and confidence interval: 3.3 · 95% CI 1.0 to 8.5
SecondaryNumber 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
Reported as:
Number · number of participants with ADEs
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 ADEsParietene DS Composite Mesh
Number of participants with incidence of ADEs Intra-Operatively0
Number of participants with incidence of ADEs at Discharge14
Number of participants with incidence of ADEs within 1 Month31
Number of participants with incidence of ADEs within 3 Months34
Number of participants with incidence of ADEs within 12 Months40
Number of participants with incidence of ADEs within 24 Months42
Statistical analysis
  • Parietene DS Composite Mesh · Number of subjects with ades: 14
  • Parietene DS Composite Mesh · Number of subjects with ades: 31
  • Parietene DS Composite Mesh · Number of subjects with ades: 34
  • Parietene DS Composite Mesh · Number of subjects with ades: 40
  • Parietene DS Composite Mesh · Number of subjects with ades: 42
SecondaryNumber 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
Reported as:
Count of participants · Participants
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
ParticipantsParietene DS Composite Mesh
Participants with hernia recurrence within 1 month0
Participants with hernia recurrence within 3 months0
Participants with hernia recurrence within 24 months4
Statistical analysis
  • Parietene DS Composite Mesh · % of subjects with recurrence within 1m: 0 · 95% CI 0 to 2.9
  • Parietene DS Composite Mesh · % of subjects with recurrence within 3m: 0 · 95% CI 0 to 3.0
  • Parietene DS Composite Mesh · % of subjects with recurrence within 24m: 4 · 95% CI 1.2 to 9.6

Adverse events

Collected over Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Parietene DS Composite Mesh2/125 (1.6%)29/125 (23.2%)20/125 (16%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventParietene DS Composite Mesh
HypoxiaRespiratory, thoracic and mediastinal disorders3/125
IleusGeneral disorders3/125
Abdominal HerniaGastrointestinal disorders2/125
Abdominal PainGastrointestinal disorders2/125
Postoperative IleusInjury, poisoning and procedural complications2/125
Atrial FibrillationCardiac disorders1/125
Ileus ParalyticGastrointestinal disorders1/125
Pancreatitis AcuteGastrointestinal disorders1/125
Abdominal Wall AbscessInfections and infestations1/125
AbscessInfections and infestations1/125
Most frequent other events
Most frequent other events
EventParietene DS Composite Mesh
SeromaInjury, poisoning and procedural complications13/125
Abdominal PainGastrointestinal disorders7/125

Baseline characteristics

Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair Approximately 125 Subjects

Age, Continuous
Age, Continuous(years)Parietene DS Composite Mesh
Overall58.0 ± 12.31
Sex: Female, Male
Sex: Female, Male(Participants)Parietene DS Composite Mesh
Female51
Male74
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Parietene DS Composite Mesh
Hispanic or Latino3
Not Hispanic or Latino121
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Parietene DS Composite Mesh
United States125
Ethnicity
Ethnicity(Participants)Parietene DS Composite Mesh
Asian1
Black or African American22
White98
Latino/Hispanic2
Middle Eastern1
Patient Does Not Want to Disclose1
Height, cm
Height, cm(centimeters)Parietene DS Composite Mesh
Mean172.5 ± 11.15
Weight, kg
Weight, kg(kilograms)Parietene DS Composite Mesh
Mean98.4 ± 15.96
BMI, kg/m^2
BMI, kg/m^2(kg/m^2)Parietene DS Composite Mesh
Mean33.2 ± 4.82

1 further baseline measures are reported on the registry.

07

Study locations

6 sites
  • Our Lady of the Lakes Regional Medical Center
    Baton Rouge, Louisiana 70808, United States
  • University of Missouri - Columbia
    Columbia, Missouri 65201, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • Hernia Center of Excellence LLC
    Newport News, Virginia 23606, United States
  • University of Wisconsin School of Medicine and Public Health
    Madison, Wisconsin 53792, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

References and documents

Study documents

  • Study protocol · Dec 3, 2021
  • Statistical analysis plan · May 16, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03495154
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Apr 11, 2018
Start date
Jun 21, 2018
Primary completion
Jul 21, 2021
Completion
Jul 6, 2022
Results posted
Nov 17, 2022
Last update
Apr 23, 2024

Study contacts

Sue Kim
study director · Medtronic - Surgical Innovations

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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