About this trial
Last updated a year ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the Participation Requirements?
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.