Italian University starts a clinical trial of Laparoscopic Hernia Defect Obliteration With ProFlor-E

The University of Cagliari (Italy) is commencing recruitment for the clinical trial of the Laparoscopic Hernia Defect Obliteration With ProFlor-E.

The condition is Inguinal Hernia.

A new clinical trial is recruiting patients in the following locations: Italy.

The trial officially began on the June 1, 2019 and is planned to complete on June 1, 2021.

This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect.

The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.

Among study population are patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias.

Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor is primary outcome measure.

The University of Cagliari (Università degli Studi di Cagliari) is a university in Cagliari, Sardinia, Italy. It was founded in 1606 and is organized in 11 faculties.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04718298