NCT04171102

Neo-nervegenesis in Inguinal Hernia Implant ProFlor

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Cagliari · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DEVICE	ProFlor Hernia implant	Inguinal hernia repair

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2019-11-20
• Last updated: 2020-06-17
• Results posted: 2020-06-11

Regulatory

• FDA-regulated device study