RecruitingNot ApplicableNCT04718168
GORE® ENFORM Biomaterial Product Study
GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients
Sponsor
W.L.Gore & Associates
Enrollment
245 participants
Start Date
May 17, 2021
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- The subject is / has:
- 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.
- At the time of index procedure, the subject is / has:
- At least 18 years old. Minimum age required by state regulations (as applicable).
- Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date.
- Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.
Exclusion Criteria28
- The subject is / has:
- 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.
- Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
- Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
- A stoma.
- Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
- Positive pregnancy or lactation status as confirmed by site standard of care.
- Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.
- At the time of index procedure, the subject is / has:
- 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 that was performed as part of a bridged procedure (i.e., 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.
- Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
- A stoma.
- Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
- Positive pregnancy or lactation status as confirmed by site standard of care.
- Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.
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Interventions
DEVICEGore ENFORM Biomaterial (Preperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
DEVICEGore ENFORM Biomaterial (Intraperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04718168
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