Back to search results

GORE® ENFORM Biomaterial for Hernia Repair

This study is evaluating the GORE® ENFORM Biomaterial, a bioabsorbable mesh used for repairing hernias. Researchers want to understand how well this mesh works and what your experience is like after surgery. You may be able to join if you are at least 18 years old and need surgery for a ventral, incisional, hiatal, or diaphragmatic hernia. The study will look at whether your hernia comes back within 24 months, and if you experience surgical site infections (SSI) or surgical site occurrences (SSO) shortly after your procedure. The current recruitment status for this study is unclear.

Study design
This is a non-randomized study with two groups of participants, one for ventral/incisional hernia repair and one for diaphragmatic/hiatal hernia repair. The study plans to enroll 245 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for hernia recurrence through 24 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04718168

GORE® ENFORM Biomaterial Product Study

Recruiting
NAAges 18+InterventionalTreatment
W.L.Gore & Associates
~245 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Gore ENFORM Biomaterial (Preperitoneal)Gore ENFORM Biomaterial (Intraperitoneal)

At a glance

Recruiting sites
7 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hernia Recurrence - Primary Device Endpoint
Measured over Through 24 months
+3 more outcomes measured

Conditions

Hernia, Ventral
Hernia, Hiatal
Hernia, Diaphragmatic
Incisional Hernia

Explore related trials

Diaphragmatic HerniaHiatal HerniaIncisional herniaVentral Hernia

Where it's being run

9 sites across 9 states
California1
Colorado1
Florida1
Illinois1
Kentucky1
North Carolina1
South Carolina1
Texas1

Study leadership

  • Todd Heniford, MD · PRINCIPAL_INVESTIGATOR · Endeavor Health

Who to contact

Heidie Hornstra O'Neill
[email protected]
443-907-3152
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Hernia Recurrence - Primary Device EndpointThrough 24 months

    Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure).

  • Incidence of SSI - Primary Procedural Endpoint 1First Post-Procedural Visit (Days 1-45)

    Incidence of SSI, reported as a composite and individually.

  • Incidence of SSO - Primary Procedural Endpoint 2First Post-Procedural Visit (Days 1-45)

    Incidence of SSO, reported as a composite and individually.

  • Incidence of SSOPI - Primary Procedural Endpoint 3First Post-Procedural Visit (Days 1-45)

    Incidence of SSOPI, reported as a composite and individually.