An interventional study of Gore ENFORM Biomaterial (Preperitoneal) and Gore ENFORM Biomaterial (Intraperitoneal) in Hernia, Ventral, Hernia, Hiatal and Hernia, Diaphragmatic, sponsored by W.L.Gore & Associates. Recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by W.L.Gore & Associates · Not applicable, Interventional, and Treatment
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.
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 long-term follow up.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 245 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pre-procedure Inclusion Criteria:
The subject is / has:
Pre-procedure Exclusion Criteria:
The subject is / has:
Post-procedure Inclusion Criteria
At the time of index procedure, the subject is / has:
Post-procedure Exclusion Criteria
At the time of index procedure, the subject is / has:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Gore ENFORM Biomaterial (Preperitoneal)
Device: Gore ENFORM Biomaterial (Intraperitoneal)
Device: Gore ENFORM Biomaterial (Preperitoneal)
Device: Gore ENFORM Biomaterial (Intraperitoneal)
ENFORM Biomaterial bioabsorbable hernia mesh
ENFORM Biomaterial bioabsorbable hernia mesh
Hernia Recurrence - Primary Device Endpoint
Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure).
Time frame: Through 24 months
Incidence of SSI - Primary Procedural Endpoint 1
Incidence of SSI, reported as a composite and individually.
Time frame: First Post-Procedural Visit (Days 1-45)
Incidence of SSO - Primary Procedural Endpoint 2
Incidence of SSO, reported as a composite and individually.
Time frame: First Post-Procedural Visit (Days 1-45)
Incidence of SSOPI - Primary Procedural Endpoint 3
Incidence of SSOPI, reported as a composite and individually.
Time frame: First Post-Procedural Visit (Days 1-45)
Freedom from potential device-related SAEs - Secondary endpoint 1
Freedom from potential device-related Serious Adverse Events will be reported descriptively with no formal goals or hypothesis.
Time frame: Through 24 months
Re-intervention at study-treated location - Secondary Endpoint 2
Surgical re-intervention in the area of the hernia repaired initially (e.g. drain insertion, infection, surface issues, second operation, etc.) will be reported descriptively with no formal goals or hypothesis.
Time frame: Through 24 months
Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3
For ventral hernia subjects; change in Quality of Life in Carolinas Comfort Scale as measured by a change in total score of the Carolinas Comfort Scale Quality of Life questionnaire given at follow-up visits. Minimum Total Score is 0 and maximum Total Score is 115. Lower score means better outcome.
Time frame: Through 24 months
Relief from GERD Symptoms - Secondary Endpoint 4
For diaphragmatic hernia subjects; relief from GERD symptoms as measured by a decrease in the total score of the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire given at follow-up visits. Total Score: Calculated by summing the individual scores to questions 1-15. Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6. Worst heartburn symptoms = 30 No heartburn symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions 10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
Time frame: Through 24 months
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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