Neo-angiogenesis in Inguinal Henia Implant ProFlor

September 8, 2020 updated by: Giuseppe Amato, University of Cagliari

Neo-angiogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair ProFlor

The investigation is aimed at specifically demonstrating the ingrowth of newly formed vascular elements within ProFlor, a 3D dynamic responsive implant for inguinal hernia repair

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 vascular elements ingrowth within the implant fabric. Histology revealed the presence of multiple angiogenetic clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, the detected vascular components assumed the typical aspect of mature veins and arteries complete in all components. The development of fully developed vascular structures, ingrowing 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.

Study Type

Observational

Enrollment (Actual)

15

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor

Description

Inclusion Criteria:

  • Patients who underwent inguinal hernia repair with the 3D dynamic responsive device named ProFlor
  • Patients undergoing recurrent inguinal hernia repair after primary repair with the 3D dynamic responsive device named ProFlor
  • Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the 3D dynamic responsive device named ProFlor

Exclusion Criteria:

  • immunosoppressive therapy, > ASA 4 classification

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Short term post inguinal hernia repair with ProFlor
Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-5 weeks post implantation
Device: ProFlor inguinal hernia device
Inguinal hernia repair
Mid term post inguinal hernia repair with ProFlor
Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 3-4 months post implantation
Device: ProFlor inguinal hernia device
Inguinal hernia repair
Long term post inguinal hernia repair with ProFlor
Determining presence and level of maturation of vascular structures in the inguinal hernia implant named ProFlor at 6-8 months post implantation
Device: ProFlor inguinal hernia device
Inguinal hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor
Time Frame: 3-5 weeks post-implantation
Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at short term post-implantation
3-5 weeks post-implantation
Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor
Time Frame: 3-4 months post implantation
Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation
3-4 months post implantation
Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor
Time Frame: 6-8 months post implantation
Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation
6-8 months post implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

July 1, 2020

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (ACTUAL)

September 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neo-angiogenesis in ProFlor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Tissue specimen and histological records upon request

IPD Sharing Time Frame

from actual date until December 2022

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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