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Evaluation of GORE® ENFORM Biomaterial for Hernia Repair

GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients

Not applicable Interventional W.L.Gore & Associates · NCT04718168

This study is testing a new material for hernia repair to see how well it works and how patients feel about it after surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment245 (estimated)
Ages18 Years and up
SexAll
SponsorW.L.Gore & Associates Industry-sponsored
Drugs / interventionsradiation
Locations9 sites (San Diego, California and 8 other locations)
Trial IDNCT04718168 on ClinicalTrials.gov

What this trial studies

This study evaluates the GORE® ENFORM Biomaterial in patients undergoing repair for various types of hernias, including ventral, hiatal, and diaphragmatic hernias. It is a multicenter, non-randomized study that collects data on the functional performance of the biomaterial and the short-term patient experience. Participants will be monitored for their surgical outcomes and overall satisfaction with the treatment. The study aims to provide insights into the effectiveness of this biomaterial in hernia repair procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require surgical repair of a single site ventral or hiatal hernia.

Not a fit: Patients with complex hernia repairs or those who have been involved in other clinical studies within the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and patient satisfaction in hernia repair procedures.

How similar studies have performed: Other studies have shown promising results with similar biomaterials in hernia repair, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

San Diego, California and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hernia, VentralHernia, HiatalHernia, DiaphragmaticIncisional Herniaherniaventralhiataldiaphragmatic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.