GORE SYNECOR

Assessment of GORE® SYNECOR Biomaterial in
Focused Patient Populations and Long-Term
Application

medical-cross
Hernia
user
All genders
person-wave 18-80
world
Recruiting now
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Overview
Principal Investigator: Nikolay Bugaev

Gore has developed and manufactures the GORE® SYNECOR Intraperitoneal Biomaterial device (GORE® SYNECOR IP Device) to offer clinicians a mesh material intended for the repair of ventral/incisional hernias that may require the addition of a nonabsorbable reinforcing or bridging material. The primary study objective is to assess SYNECOR Biomaterial performance on incisional hernia patients over an extended amount of time through multiple methods. The secondary study objective is to conduct configuration-specific assessments to address areas of medical interest. Including; -Characterizing the frequency and significance of complications in patient populations of differing risk by Modified Ventral Hernia Working Group (mVHWG) grade (SYNECOR IP Device) -Characterizing the frequency and significance of complications in patient populations with the implanted Extended Size Mesh (SYNECOR PRE Device)

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Nikolay Bugaev

Study details
Inclusion Criteria
  • - De-novo ventral/incisional hernia amenable to repair with GORE®
    SYNECOR IP Biomaterial
  • - Clean wound (CDC Wound Class I)
  • -mVHWG Grade 1 or 2
Exclusion Criteria
  • Wound is either clean-contaminated, contaminated, or dirty-infecte
Study Requirements

There will be 8 visits. Prescreening, procedure day, 12 month, 24 month, 36 month, 48 month, 60 month. The Patient will be participating for 60 months. The 12-, 36-, 48 month visits will be remote. All patients who sign an informed consent will be considered entered into the screening phase of the study. The following evaluations will be conducted at the screening visit or must have been completed no more than 30 days prior to enrollment, except as noted: Inclusion / Exclusion criteria Informed consent Demographics Medical history Physical examination – including hernia status Pregnancy test (as applicable; performed per site standard of care) Carolinas Comfort Scale (CCS) Questionnaire 36-Item Short Form Survey (SF-36) Questionnaire