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Neo-nervegenesis in Inguinal Hernia Implant ProFlor

Primary Purpose

Inguinal Hernia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ProFlor Hernia implant

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Hernia implants, Biologic response, Neo-nervegenesis, Regenerative scaffold

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Short term post inguinal hernia repair wit ProFlor

Mid term post inguinal hernia repair wit ProFlor

Long term post inguinal hernia repair wit ProFlor

Arm Description

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-5 weeks post implantation

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-4 months post implantation

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation

Outcomes

Primary Outcome Measures

Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor

Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation

Secondary Outcome Measures

Full Information

NCT ID

NCT04171102

First Posted

November 15, 2019

Last Updated

June 10, 2020

Sponsor

University of Cagliari

1. Study Identification

Unique Protocol Identification Number

NCT04171102

Brief Title

Neo-nervegenesis in Inguinal Hernia Implant ProFlor

Official Title

Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

January 2013 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cagliari

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

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 neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inguinal Hernia

Keywords

Hernia implants, Biologic response, Neo-nervegenesis, Regenerative scaffold

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Short term post inguinal hernia repair wit ProFlor

Arm Type

Active Comparator

Arm Description

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-5 weeks post implantation

Arm Title

Mid term post inguinal hernia repair wit ProFlor

Arm Type

Active Comparator

Arm Description

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-4 months post implantation

Arm Title

Long term post inguinal hernia repair wit ProFlor

Arm Type

Active Comparator

Arm Description

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation

Intervention Type

Device

Intervention Name(s)

ProFlor Hernia implant

Intervention Description

Inguinal hernia repair

Primary Outcome Measure Information:

Title

Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor

Description

Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation

Time Frame

3 weeks until 8 months post-implantation

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Amato, MD

Organizational Affiliation

University of Cagliari

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Tissue specimen and histological records upon request

IPD Sharing Time Frame

from actual date until december 2021

IPD Sharing Access Criteria

personal contact

Citations:

PubMed Identifier

21752035

Citation

Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.

Results Reference

background

PubMed Identifier

25626584

Citation

Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416.

Results Reference

background

PubMed Identifier

30318605

Citation

Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calo P. Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair. Artif Organs. 2018 Dec;42(12):1216-1223. doi: 10.1111/aor.13286. Epub 2018 Oct 14.

Results Reference

background

PubMed Identifier

32169570

Citation

Amato G, Agrusa A, Puleio R, Calo P, Goetze T, Romano G. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. Int J Surg. 2020 Apr;76:114-119. doi: 10.1016/j.ijsu.2020.02.046. Epub 2020 Mar 10.

Results Reference

result

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Neo-nervegenesis in Inguinal Hernia Implant ProFlor

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