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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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.
. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.