NCT03912662

ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

Poetry Study - ProGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Interventional, prospective, multicenter, post-marketing clinical follow-up study. After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and patient state of health. As the clinical data needed for the study corresponds with those collected by Club Hernie registry, the clinical study will use the established registry database to collect performance and safety data on the prevention of incisional hernias within 24 months post operatively.

Detailed description

The primary objective of this investigation is to confirm the efficacy of ProGrip™ Self-gripping Polyester Mesh to reduce the incidence of incisional hernia within 24 months post-operatively in subjects undergoing procedures with midline laparotomies. Secondary Objective The secondary objective of this investigation is to confirm the safety of ProGrip™ Self-gripping Polyester Mesh through the occurrence of adverse device effects or procedure related adverse events following the use of ProGrip™ Self- gripping Polyester Mesh in subjects undergoing procedures with midline laparotomies.

Conditions

• Incisional Hernia

Interventions

Type	Name	Description
DEVICE	Mesh augmented reinforcement	Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh

Timeline

• Start date: 2019-09-18
• Primary completion: 2022-09-12
• Completion: 2022-09-12
• First posted: 2019-04-11
• Last updated: 2025-12-03
• Results posted: 2025-12-03

Locations

11 sites across 1 country: France