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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

Tracking Information
First Submitted Date September 1, 2020
First Posted Date September 9, 2020
Last Update Posted Date September 10, 2020
Actual Study Start Date January 2013
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2020)
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neo-angiogenesis in Inguinal Henia Implant ProFlor
Official Title Neo-angiogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair ProFlor
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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tissue specimens excised from ProFlor prosthesis implanted in patients who underwent inguinal hernia repair
Sampling Method Probability Sample
Study Population Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
Condition Inguinal Hernia
Intervention Device: ProFlor inguinal hernia device
Inguinal hernia repair
Study Groups/Cohorts
  • 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
    Intervention: Device: ProFlor inguinal hernia device
  • 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
    Intervention: Device: ProFlor inguinal hernia device
  • 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
    Intervention: Device: ProFlor inguinal hernia device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 1, 2020)
15
Original Actual Enrollment Same as current
Actual Study Completion Date July 2020
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04541316
Other Study ID Numbers Neo-angiogenesis in ProFlor
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Tissue specimen and histological records upon request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: from actual date until December 2022
Responsible Party Giuseppe Amato, University of Cagliari
Study Sponsor University of Cagliari
Collaborators Not Provided
Investigators
Principal Investigator: Giuseppe Amato University of Cagliari
PRS Account University of Cagliari
Verification Date September 2020