Neo-angiogenesis in Inguinal Henia Implant ProFlor

Neo-angiogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair ProFlor

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04541316

Enrollment

Registered

2020-09-09

Start date

2013-01-31

Completion date

2020-07-31

Last updated

2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Hernia implants, Biologic response, Neo-angiogenesis, Regenerative scaffolds

Brief summary

The investigation is aimed at specifically demonstrating the ingrowth of newly formed vascular elements within ProFlor, 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 vascular elements ingrowth within the implant fabric. Histology revealed the presence of multiple angiogenetic clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, the detected vascular components assumed the typical aspect of mature veins and arteries complete in all components. The development of fully developed vascular structures, ingrowing 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.

Interventions

DEVICEProFlor inguinal hernia device

Inguinal hernia repair

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients who underwent inguinal hernia repair with the 3D dynamic responsive device named ProFlor * Patients undergoing recurrent inguinal hernia repair after primary repair with the 3D dynamic responsive device named ProFlor * Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the 3D dynamic responsive device named ProFlor

Exclusion criteria

* immunosoppressive therapy, \> ASA 4 classification

Design outcomes

Primary

Measure	Time frame	Description
Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor	3-5 weeks post-implantation	Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at short term post-implantation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026