Clinical trial NCT03495154: Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
Official title: A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2018-04-11
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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 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

Primary outcomes:
measure: Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
timeFrame: 12 months post surgery
Secondary outcomes:
measure: 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.
timeFrame: operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery
measure: 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
timeFrame: 1 month, 3 months, and 24 months post-surgery
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Our Lady of the Lakes Regional Medical Center
state: Louisiana
city: Columbia
country: United States
facility: University of Missouri - Columbia
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Newport News
country: United States
facility: Hernia Center of Excellence LLC
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medtronic - Surgical Innovations
name: Sue Kim
role: STUDY_DIRECTOR
References: