N/A
N=15
Neo-nervegenesis in Inguinal Hernia Implant ProFlor
Inguinal Hernia
Bottom Line
View on ClinicalTrials.gov: NCT04171102 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor — 999.75; 1044; 2094 μm^2 — p=0.028
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ProFlor Hernia implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Cagliari
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor |
999.75; 1044; 2094 | 0.028 sig |
Summary
The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.
Eligibility Criteria
Inclusion Criteria
- Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
- Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor
- Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor
Exclusion Criteria
- Patients who underwent inguinal hernia repair with conventional flat meshes
Data sourced from ClinicalTrials.gov (NCT04171102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.