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OpenTrials
Completed

NCT Number: NCT04171102

Neo-nervegenesis in Inguinal Hernia Implant ProFlor

The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.

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 prosthetic device named ProFlor
  • Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor
  • Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor

Exclusion criteria

  • Patients who underwent inguinal hernia repair with conventional flat meshes

Treatment and study plan

ProFlor Hernia implant

Device

Inguinal hernia repair

Primary outcomes

  1. Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor

    Time frame: 3 weeks until 8 months post-implantation

    Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2019
Registry last updated
Jun 17, 2020

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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