GORE® ENFORM Biomaterial Product Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorW.L.Gore & Associates
About this trial
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.
Eligibility criteria
Qualifiers
At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
Disqualifiers
Treated in another drug or medical device study within 1 year of study enrollment.
Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).
A BMI >40.
Trial design
Treatments tested in this trial
- Gore ENFORM Biomaterial (Preperitoneal)
- Gore ENFORM Biomaterial (Intraperitoneal)
Treatment groups
245 Participants
are divided into 4 treatment groupsLocations
9California
University of California - San Diego92093, San Diego United States
Colorado
Institute of Esophageal and Reflux Surgery80124, Denver United States
Florida
Sarasota Memorial HealthCare System34239, Sarasota United States
Illinois
Northshore University Health System Research Institute60201, Evanston United States
Sponsors and collaborators
W.L.Gore & Associates
Lead sponsor
Source ClinicalTrials.gov