GORE® ENFORM Biomaterial Product Study

Launched by W.L.GORE & ASSOCIATES · Jan 15, 2021

Keywords

ClinConnect Summary

The GORE® ENFORM Biomaterial Product Study is looking at how well a special material called GORE® ENFORM works for repairing different types of hernias, specifically ventral (front abdominal wall), hiatal (upper stomach), diaphragmatic (diaphragm), and incisional hernias (from previous surgeries). This study is currently recruiting participants aged 18 and older who are scheduled for surgery to repair a hernia using this material. To be eligible, participants should have a clean surgical wound and meet certain health criteria, such as having a manageable body mass index (BMI) and no serious infections or conditions that would complicate healing.

If you join this study, you can expect to have your surgery as planned and then be monitored to see how well the GORE® ENFORM material performs over time. Researchers want to gather information on how this product helps in the recovery process and its overall effectiveness. It's important to know that certain conditions, like being pregnant or having a very high BMI, may prevent someone from participating. This study aims to improve hernia repair techniques and help future patients receive better care.

Gender

ALL

Eligibility criteria

• Pre-procedure Inclusion Criteria:
• The subject is / has:
• • 1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
• • 2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
• • 3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
• • 4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
• • 5. Willing to provide informed consent and comply with follow-up requirements.
• Pre-procedure Exclusion Criteria:
• The subject is / has:
• • 1. Treated in another drug or medical device study within 1 year of study enrollment.
• • 2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
• • 3. 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).
• • 4. A BMI \>40.
• • 5. Evidence of a systemic infection.
• • 6. Cirrhosis or undergoing dialysis.
• • 7. A wound-healing disorder.
• • 8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
• • 9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
• • 10. A stoma.
• • 11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
• • 12. Positive pregnancy or lactation status as confirmed by site standard of care.
• • 13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.
• • Post-procedure Inclusion Criteria
• At the time of index procedure, the subject is / has:
• • 1. At least 18 years old. Minimum age required by state regulations (as applicable).
• • 2. 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.
• • 3. Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.
• • Post-procedure Exclusion Criteria
• At the time of index procedure, the subject is / has:
• • 1. Treated in another drug or medical device study within 1 year of study enrollment.
• • 2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
• • 3. 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).
• • 4. A BMI \>40.
• • 5. Evidence of a systemic infection.
• • 6. Cirrhosis or undergoing dialysis.
• • 7. A wound-healing disorder.
• • 8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
• • 9. Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
• • 10. A stoma.
• • 11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
• • 12. Positive pregnancy or lactation status as confirmed by site standard of care.
• • 13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.