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Neo-angiogenesis in Inguinal Henia Implant ProFlor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541316
Recruitment Status : Completed
First Posted : September 9, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Giuseppe Amato, University of Cagliari

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

Condition or disease Intervention/treatment
Inguinal Hernia Device: ProFlor inguinal hernia device

Detailed Description:
Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the vascular elements ingrowth within the implant fabric. Histology revealed the presence of multiple angiogenetic clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, the detected vascular components assumed the typical aspect of mature veins and arteries complete in all components. The development of fully developed vascular structures, ingrowing together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Neo-angiogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair ProFlor
Actual Study Start Date : January 2013
Actual Primary Completion Date : January 2020
Actual Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
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
Inguinal hernia repair

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
Inguinal hernia repair

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
Inguinal hernia repair




Primary Outcome Measures :
  1. Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor [ Time Frame: 3-5 weeks post-implantation ]
    Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at short term post-implantation

  2. Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor [ Time Frame: 3-4 months post implantation ]
    Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation

  3. Ingrowth of Newly Formed Vascular Elements Within Hernia Implant ProFlor [ Time Frame: 6-8 months post implantation ]
    Post-operative assessment of neo-angiogenesis within hernia implant ProFlor at midterm post-implantation


Biospecimen Retention:   Samples With DNA
Tissue specimens excised from ProFlor prosthesis implanted in patients who underwent inguinal hernia repair


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • immunosoppressive therapy, > ASA 4 classification

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541316


Sponsors and Collaborators
University of Cagliari
Investigators
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Principal Investigator: Giuseppe Amato University of Cagliari
Additional Information:
Publications:
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Responsible Party: Giuseppe Amato, Consultant Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT04541316    
Other Study ID Numbers: Neo-angiogenesis in ProFlor
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Tissue specimen and histological records upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: from actual date until December 2022

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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, University of Cagliari:
Hernia implants
Biologic response
Neo-angiogenesis
Regenerative scaffolds
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Neovascularization, Pathologic
Pathological Conditions, Anatomical
Hernia, Abdominal
Metaplasia
Pathologic Processes