MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor

Study Overview
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Brief Summary
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Demonstrating through MRI sequuences the regenerative features of the 3D inguinal hernia scaffold ProFlor

Detailed Description
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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

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

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: ProFlor inguinal hernia device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short term post inguinal hernia repair with ProFlor<br>MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 1 to 3 months before to assess tissue incorporation into the 3D scaffold | Device: ProFlor inguinal hernia device<br>* Device follow up after inguinal hernia repair with ProFlor<br>|
| Active Comparator: Mid term post inguinal hernia repair with ProFlor<br>MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 4 to 7 months before to assess tissue incorporation into the 3D scaffold | Device: ProFlor inguinal hernia device<br>* Device follow up after inguinal hernia repair with ProFlor<br>|
| Active Comparator: Long term post inguinal hernia repair with ProFlor<br>MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor after 8 months and beyond to assess tissue incorporation into the 3D scaffold | Device: ProFlor inguinal hernia device<br>* Device follow up after inguinal hernia repair with ProFlor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 8 months post implantation |