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

Medtronic

Status: Completed

Conditions: Ventral Hernia

Treatments: Device: Parietene DS Composite Mesh

Study type: Interventional

Funder types: Industry

Identifiers

NCT03495154

MDT17051PDS

Details and patient eligibility

About

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)

Full 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)

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

Parietene DS Composite Mesh

Experimental group

Description:

Patients treated with Parietene DS Composite Mesh

Treatment:

Device: Parietene DS Composite Mesh