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 groupsSponsors and collaborators
Source ClinicalTrials.gov