NCT04762264

MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor

A 3D Regenerative Scaffold for Inguinal Hernia Repair. MR Imaging and Histological Cross Evidence.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Cagliari · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Demonstrating through MRI sequuences the regenerative features of the 3D inguinal hernia scaffold ProFlor

Detailed description

The biological response of the 3D inguinal hernia scaffold ProFlor has been evaluated through MRI signal intensity (SI) at three defined post-implantation stages: short, mid and long term. The SI of ProFlor has been compared to the SI of the neighbouring muscles and fat. As additional proof, histology of tissue specimens excised at the identical post-implantation stages from porcine models in the fame of a previous experimental attempt were also evaluated. The results of this experimental trial have ben already published in 2011 - ref: A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artificial Organs 2011;35(8):E181-E190

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DEVICE	ProFlor inguinal hernia device	Device follow up after inguinal hernia repair with ProFlor

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2021-02-21
• Last updated: 2022-05-16

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study