Neo-angiogenesis in Inguinal Henia Implant ProFlor

NCT04541316 | Completed FDA Device

• 1 other identifier: Neo-angiogenesis in ProFlor
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Inguinal Hernia

Keywords

Hernia implants; Biologic response; Neo-angiogenesis; Regenerative scaffolds

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

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

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

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

Interventions

ProFlor inguinal hernia device DEVICE

Inguinal hernia repair

Long term post inguinal hernia repair with ProFlor; Mid term post inguinal hernia repair with ProFlor; Short term post inguinal hernia repair with ProFlor

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• immunosoppressive therapy, \> ASA 4 classification

Sponsors & Collaborators

• University of Cagliari: lead

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: 21752035 BACKGROUND

• 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: 25626584 BACKGROUND

• 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: 30318605 BACKGROUND

• 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: 32169570 BACKGROUND

Related Links

• ProFlor inguinal hernia repair: features, procedural steps and clinical data

Biospecimen

Retention: SAMPLES WITH DNA

Tissue specimens excised from ProFlor prosthesis implanted in patients who underwent inguinal hernia repair

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Amato

  University of Cagliari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Professor

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: January 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: from actual date until December 2022