NCT04718298

Laparoscopic Hernia Defect Obliteration With ProFlor-E

Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E - Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Cagliari · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 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.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DEVICE	ProFlor laparoscopic technique	Inguinal hernia repair laparoscopic

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2021-01-22
• Last updated: 2021-09-29

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study