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NCT04541316 Clinical Trial

Neo-angiogenesis in Inguinal Henia Implant ProFlor

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04541316
Other study ID # Neo-angiogenesis in ProFlor
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date July 2020

Study information
Verified date September 2020
Source University of Cagliari
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date July 2020
Est. primary completion date January 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• ProFlor inguinal hernia device
Inguinal hernia repair

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Cagliari

References & Publications (4)

Amato G, Agrusa A, Puleio R, Calò 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. — View 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. — View 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. — View Citation

Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calò 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. — View Citation

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