Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial
  • Device: Gore ENFORM Biomaterial (Preperitoneal)
    ENFORM Biomaterial bioabsorbable hernia mesh
Experimental
Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial
  • Device: Gore ENFORM Biomaterial (Intraperitoneal)
    ENFORM Biomaterial bioabsorbable hernia mesh
Experimental
Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial
  • Device: Gore ENFORM Biomaterial (Preperitoneal)
    ENFORM Biomaterial bioabsorbable hernia mesh
Experimental
Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial
  • Device: Gore ENFORM Biomaterial (Intraperitoneal)
    ENFORM Biomaterial bioabsorbable hernia mesh

Recruiting Locations

University of Texas Health Science Center at Houson
Houston, Texas 77401
Contact:
Elaine Tran
713-486-1346
Elaine.Tran@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
W.L.Gore & Associates

Study Contact

Bronte Emery
800-437-8181
ENF1806@wlgore.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.