Laparoscopic Hernia Defect Obliteration With ProFlor-E

NCT ID: NCT04718298

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-06-01

Brief Summary

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

Detailed Description

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The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

feasibility study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inguinal hernia repair laparoscopic

recurrent inguinal hernia after open repair or bilateral hernia patients

Group Type EXPERIMENTAL

ProFlor laparoscopic technique

Intervention Type DEVICE

Inguinal hernia repair laparoscopic

Interventions

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ProFlor laparoscopic technique

Inguinal hernia repair laparoscopic

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* ASA \>4 patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Amato

Consultant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Amato, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cagliari - University of Palermo

Locations

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University of Palermo

Palermo, Please Select, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 21752035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25626584 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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Laparoscopic ProFlor approach

Identifier Type: -

Identifier Source: org_study_id

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