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Progrip Ventral Study for Sublay Repair

NCT01622127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2024-06-03

No results posted yet for this study

Summary

A novel concept of self-gripping mesh has been developed to achieve secure and long-term posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation. The self-fixation of the mesh to the underlying tissues is instantly achieved at application, limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and damage cutaneous nerves), and providing a near tension-¬free repair.

Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and painless treatment of incisional hernias and provides secure and efficient fixation mesh. On this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional hernia defect treatment. In order to assess the clinical outcomes following the use of ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has been initiated.

Conditions

  • Primary Ventral and Incisional Hernia Repair

Interventions

DEVICE

Parietex ProGrip™

ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Frederik Berrevoet, MD, PhD · University Hospital, Ghent

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-06-30
Completion
2023-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01622127 on ClinicalTrials.gov