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Completed

NCT Number: NCT04762264

MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor

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

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Palermo - Italy

Palermo, 90127, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ProFlor inguinal hernia device

Device

Device follow up after inguinal hernia repair with ProFlor

Primary outcomes

  1. tissue incorporation into ProFlor in the short term postop.

    Time frame: 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

  2. tissue incorporation into ProFlor in the mid term postop.

    Time frame: 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

  3. tissue incorporation into ProFlor in the long term postop.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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