MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor

May 13, 2022 updated by: Giuseppe Amato, University of Cagliari

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • University of Palermo - Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional 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
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
Device follow up after inguinal hernia repair with ProFlor
Active Comparator: Mid term post inguinal hernia repair with ProFlor
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
Device follow up after inguinal hernia repair with ProFlor
Active Comparator: Long term post inguinal hernia repair with ProFlor
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
Device follow up after inguinal hernia repair with ProFlor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1- 3 weeks post implantation
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
4-7 months post implantation
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
8 months post implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR imaging of ProFlor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

upon request within

IPD Sharing Time Frame

one year after study completion

IPD Sharing Access Criteria

email contact

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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