Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Inguinal Hernia
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: feasibility studyMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 85 years
Gender
Only males

Description

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 t...

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.

Tracking Information

NCT #
NCT04718298
Collaborators
Not Provided
Investigators
Principal Investigator: Giuseppe Amato, MD University of Cagliari - University of Palermo