GORE® ENFORM Biomaterial Product Study (NCT04718168) | Clinical Trial Compass
RecruitingNot Applicable
GORE® ENFORM Biomaterial Product Study
United States245 participantsStarted 2021-05-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Willing to provide informed consent and comply with follow-up requirements.
Exclusion criteria
✕. 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.
✕. Evidence of a systemic infection.
✕. Cirrhosis or undergoing dialysis.
✕. A wound-healing disorder.
✕
What they're measuring
1
Hernia Recurrence - Primary Device Endpoint
Timeframe: Through 24 months
2
Incidence of SSI - Primary Procedural Endpoint 1
Timeframe: First Post-Procedural Visit (Days 1-45)
3
Incidence of SSO - Primary Procedural Endpoint 2
Timeframe: First Post-Procedural Visit (Days 1-45)
4
Incidence of SSOPI - Primary Procedural Endpoint 3
Timeframe: First Post-Procedural Visit (Days 1-45)