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Status:

COMPLETED

International Hernia Mesh Registry

Lead Sponsor:

Ethicon, Inc.

Conditions:

Hernia

Eligibility:

All Genders

18+ years

Brief Summary

This is an open-label, multi-center, long-term, prospective hernia mesh registry. A minimum of 4,800 hernia patients will be enrolled from approximately 60 active sites globally

Detailed Description

Patients will be followed for 2-years post-implantation, in a post-market setting to help identify best practices leading to lower recurrence rates and decreases in chronic pain, associated with the h...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Patients must satisfy the following criteria before entering the registry:
  • Provide written informed consent prior to surgery;
  • Male or female patients that are \> 18 years of age;
  • Be literate and able to understand a language available in the Registry Patient Questionnaires;
  • Scheduled to receive a surgically implanted ETHICON synthetic mesh using any fixation method or a non-ETHICON synthetic mesh which must be fixated with SECURESTRAP® or SECURESTRAP® Open for repair of a hernia defect;
  • Agree to provide long-term, outcomes data to Quintiles Outcome;
  • Agree to provide contact information;
  • Two or more pieces of the same mesh product sewn together will be considered as one mesh, and is therefore allowed in this registry
  • Exclusion Criteria
  • Patients who meet any of the following criteria will be excluded from participating in the registry:
  • Patients that are \<18 years of age;
  • Patients who have been entered into the registry previously;
  • Employees of the investigator or registry center with direct involvement in the proposed registry or other studies under the direction of that investigator or registry center and employees of ETHICON;
  • Patients suffering from and currently receiving medication for chronic pain (defined as suffering pain for greater than 3 months);
  • Patients known to be suffering from pre-existing chronic depression;
  • Patients currently known or suspected to abuse drugs or alcohol;
  • Patients suffering from a terminal illness (e.g. cancer);
  • Patients requiring multiple hernia repairs (including bilateral inguinal/femoral);
  • Patients requiring any other (concomitant) surgical procedure;
  • Patients suffering from an ongoing infection, sepsis, contaminated mesh or fistulas;
  • Patients who require hiatal, paraesophageal or diaphragmatic hernia repair;
  • Patients requiring two different types of meshes;
  • Patients requiring two or more meshes not sewn together
  • Patients scheduled to receive a surgically implanted biologic mesh product for repair of a hernia defect

Exclusion

    Key Trial Info

    Start Date :

    September 1 2007

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    January 25 2021

    Estimated Enrollment :

    5179 Patients enrolled

    Trial Details

    Trial ID

    NCT00622583

    Start Date

    September 1 2007

    End Date

    January 25 2021

    Last Update

    June 5 2023

    Active Locations (54)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 14 (54 locations)

    1

    Florida Hospital Celebration Health

    Celebration, Florida, United States, 34747

    2

    Center for Hernia Repair

    Sarasota, Florida, United States, 34139

    3

    Steward Norwood Hospital

    Norwood, Massachusetts, United States, 02062

    4

    University of Missouri-Columbia

    Columbia, Missouri, United States, 65212