NCT04718298

Brief Summary

This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

July 15, 2020

Last Update Submit

September 28, 2021

Conditions

Inguinal Hernia

Keywords

Inguinal herniaLaparoscopic inguinal hernia repairInguinal hernia defect obliterationFixation free hernia repairRegenerative scaffolds

Outcome Measures

Primary Outcomes (1)

  • Feasibility of inguinal hernia defect obliteration with ProFlor

    Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor

    intraoperative

Secondary Outcomes (1)

  • Postoperative pain

    from early stage until 18 months postop

Study Arms (1)

Inguinal hernia repair laparoscopic

EXPERIMENTAL

recurrent inguinal hernia after open repair or bilateral hernia patients

Device: ProFlor laparoscopic technique

Interventions

ProFlor laparoscopic techniqueDEVICE

Inguinal hernia repair laparoscopic

Inguinal hernia repair laparoscopic

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias

You may not qualify if:

  • ASA \>4 patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Palermo

Palermo, Please Select, 90100, Italy

Location

Related Publications (3)

  • 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, Goetze T, Cicero L, Gulotta E, Calò PG, Agrusa A Fixation free inguinal hernia repair with the 3D dynamic responsive prosthesis ProFlor: Features, procedural steps and long-term results. International Journal of Surgery Open 2019; 21:34-4

    BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Giuseppe Amato, MD

    University of Cagliari - University of Palermo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: feasibility study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Professor

Study Record Dates

First Submitted

July 15, 2020

First Posted

January 22, 2021

Study Start

June 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)