NCT04762264 - MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor | Crick

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

30

Conditions

Inguinal Hernia

Interventions

ProFlor inguinal hernia deviceDEVICE

Device follow up after inguinal hernia repair with ProFlor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * patients who underwent inguinal hernia repair with the 3D inguinal hernia scaffold ProFlor Exclusion Criteria: * all individuals who underwent inguinal hernia repair withouth the 3D inguinal hernia scaffold ProFlor

Locations (1)

University of Palermo - Italy

Palermo, Italy

Outcomes

Primary Outcomes

tissue incorporation into ProFlor in the short term postop.

evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor

Time frame: 1- 3 weeks post implantation

tissue incorporation into ProFlor in the mid term postop.

evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor

Time frame: 4-7 months post implantation

tissue incorporation into ProFlor in the long term postop.

evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor

Time frame: 8 months post implantation