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Laparoscopic Hernia Defect Obliteration With ProFlor-E

Sponsor
University of Cagliari (Other)
Overall Status
Completed
CT.gov ID
NCT04718298
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
24
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: ProFlor laparoscopic technique
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
feasibility studyfeasibility study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E - Feasibility Study
Actual Study Start Date :
Jun 1, 2019
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Inguinal hernia repair laparoscopic

recurrent inguinal hernia after open repair or bilateral hernia patients

Device: ProFlor laparoscopic technique
Inguinal hernia repair laparoscopic

Outcome Measures

Primary Outcome Measures

  1. Feasibility of inguinal hernia defect obliteration with ProFlor [intraoperative]

    Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor

Secondary Outcome Measures

  1. Postoperative pain [from early stage until 18 months postop]

    assessment of postoperative pain through Visual Analogue Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias
Exclusion Criteria:
  • ASA >4 patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Palermo Palermo Please Select Italy 90100

Sponsors and Collaborators

  • University of Cagliari

Investigators

  • Principal Investigator: Giuseppe Amato, MD, University of Cagliari - University of Palermo

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Giuseppe Amato, Consultant Professor, University of Cagliari
ClinicalTrials.gov Identifier:
NCT04718298
Other Study ID Numbers:
  • Laparoscopic ProFlor approach
First Posted:
Jan 22, 2021
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Giuseppe Amato, Consultant Professor, University of Cagliari
Inguinal hernia
Laparoscopic inguinal hernia repair
Inguinal hernia defect obliteration
Fixation free hernia repair
Regenerative scaffolds
Additional relevant MeSH terms:
Hernia
Hernia, Inguinal

Study Results

No Results Posted as of Sep 29, 2021