MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor

University of Cagliari

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: ProFlor inguinal hernia device

Study type: Interventional

Funder types: Other

Identifiers

NCT04762264

MR imaging of ProFlor

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Short term post inguinal hernia repair with ProFlor

Active Comparator group

Description:

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

Treatment:

Device: ProFlor inguinal hernia device

Mid term post inguinal hernia repair with ProFlor

Active Comparator group

Description:

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

Treatment:

Device: ProFlor inguinal hernia device

Long term post inguinal hernia repair with ProFlor

Active Comparator group

Description:

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

Treatment:

Device: ProFlor inguinal hernia device