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

Ventral Hernia Clinical Trial

— PPDS  

Official title:

A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03495154
• Other study ID #: MDT17051PDS
• Status: Completed
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: July 6, 2022

Study information

• Verified date: April 2024
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 6, 2022
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• Parietene DS Composite Mesh
All subjects enrolled will receive the Parietene DS Composite Mesh

Locations

Country	Name	City	State
United States	Our Lady of the Lakes Regional Medical Center	Baton Rouge	Louisiana
United States	University of Missouri - Columbia	Columbia	Missouri
United States	The Ohio State University	Columbus	Ohio
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hernia Center of Excellence LLC	Newport News	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair		12 months post surgery
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.		operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery
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		1 month, 3 months, and 24 months post-surgery