ProFlor Hernia implant
DeviceInguinal hernia repair
NCT Number: NCT04171102
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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Notify Me18 year and older
Male
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inguinal hernia repair
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
University of Cagliari
Other
Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor
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