NCT04171102

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 11, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

3.9 years

First QC Date

November 15, 2019

Results QC Date

April 16, 2020

Last Update Submit

June 10, 2020

Conditions

Inguinal Hernia

Keywords

Hernia implantsBiologic responseNeo-nervegenesisRegenerative scaffold

Outcome Measures

Primary Outcomes (1)

  • 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

    3 weeks until 8 months post-implantation

Study Arms (3)

Short term post inguinal hernia repair wit ProFlor

ACTIVE COMPARATOR

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

Device: ProFlor Hernia implant

Mid term post inguinal hernia repair wit ProFlor

ACTIVE COMPARATOR

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

Device: ProFlor Hernia implant

Long term post inguinal hernia repair wit ProFlor

ACTIVE COMPARATOR

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

Device: ProFlor Hernia implant

Interventions

ProFlor Hernia implantDEVICE

Inguinal hernia repair

Long term post inguinal hernia repair wit ProFlorMid term post inguinal hernia repair wit ProFlorShort term post inguinal hernia repair wit ProFlor

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who underwent inguinal hernia repair with conventional flat meshes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 21752035BACKGROUND

  • 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.

    PMID: 25626584BACKGROUND

  • 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.

    PMID: 30318605BACKGROUND

  • 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.

    PMID: 32169570RESULT

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Prof. Dr. Giuseppe Amato
Organization
University of Cagliari
amatomed@gmail.com
337963197

Study Officials

  • Giuseppe Amato, MD

    University of Cagliari

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Professor

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 20, 2019

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 17, 2020

Results First Posted

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

Tissue specimen and histological records upon request

Time Frame
from actual date until december 2021
Access Criteria
personal contact