MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor

NCT04762264 | Completed FDA Device

• 1 other identifier: MR imaging of ProFlor
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Demonstrating through MRI sequuences the regenerative features of the 3D inguinal hernia scaffold ProFlor

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (3)

• tissue incorporation into ProFlor in the short term postop.

  evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor

  1- 3 weeks post implantation

• tissue incorporation into ProFlor in the mid term postop.

  evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor

  4-7 months post implantation

• tissue incorporation into ProFlor in the long term postop.

  evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor

  8 months post implantation

Study Arms (3)

Short term post inguinal hernia repair with ProFlor

ACTIVE COMPARATOR

MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 1 to 3 months before to assess tissue incorporation into the 3D scaffold

Device: ProFlor inguinal hernia device

Mid term post inguinal hernia repair with ProFlor

ACTIVE COMPARATOR

MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 4 to 7 months before to assess tissue incorporation into the 3D scaffold

Device: ProFlor inguinal hernia device

Long term post inguinal hernia repair with ProFlor

ACTIVE COMPARATOR

MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor after 8 months and beyond to assess tissue incorporation into the 3D scaffold

Device: ProFlor inguinal hernia device

Interventions

ProFlor inguinal hernia device DEVICE

Device follow up after inguinal hernia repair with ProFlor

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+)

You may qualify if:

• patients who underwent inguinal hernia repair with the 3D inguinal hernia scaffold ProFlor

You may not qualify if:

• all individuals who underwent inguinal hernia repair withouth the 3D inguinal hernia scaffold ProFlor

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

University of Palermo - Italy

Palermo, 90127, Italy

Location

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

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: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Professor

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: January 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 16, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year after study completion
• Access Criteria: email contact

Locations

IT (1)