MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Device: ProFlor inguinal hernia device

• Registration Number: NCT04762264
• Lead Sponsor: University of Cagliari

Brief 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

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-01
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Short term post inguinal hernia repair with ProFlor	ProFlor inguinal hernia device	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
Mid term post inguinal hernia repair with ProFlor	ProFlor inguinal hernia device	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
Long term post inguinal hernia repair with ProFlor	ProFlor inguinal hernia device	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

Primary Outcome Measures

Name	Time	Method
tissue incorporation into ProFlor in the mid term postop.	4-7 months post implantation	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
tissue incorporation into ProFlor in the long term postop.	8 months post implantation	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
tissue incorporation into ProFlor in the short term postop.	1- 3 weeks post implantation	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

Trial Locations

Locations (1)

University of Palermo - Italy; 🇮🇹 Palermo, Italy