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Status:

RECRUITING

GORE® ENFORM Biomaterial Product Study

Lead Sponsor:

W.L.Gore & Associates

Conditions:

Hernia, Ventral

Hernia, Hiatal

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary obj...

Detailed Description

A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary obj...

Eligibility Criteria

Inclusion

  • Pre-procedure
  • The subject is / has:
  • At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
  • An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
  • A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
  • An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
  • Willing to provide informed consent and comply with follow-up requirements.
  • Pre-procedure

Exclusion

  • The subject is / has:
  • Treated in another drug or medical device study within 1 year of study enrollment.
  • Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
  • 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).
  • A BMI \>40.
  • Evidence of a systemic infection.
  • Cirrhosis or undergoing dialysis.
  • A wound-healing disorder.
  • Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
  • Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
  • A stoma.
  • Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
  • Positive pregnancy or lactation status as confirmed by site standard of care.
  • 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:
  • At least 18 years old. Minimum age required by state regulations (as applicable).
  • 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.
  • 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:
  • Treated in another drug or medical device study within 1 year of study enrollment.
  • Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
  • 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).
  • A BMI \>40.
  • Evidence of a systemic infection.
  • Cirrhosis or undergoing dialysis.
  • A wound-healing disorder.
  • Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
  • Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
  • A stoma.
  • Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
  • Positive pregnancy or lactation status as confirmed by site standard of care.
  • Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.

Key Trial Info

Start Date :

May 17 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

245 Patients enrolled

Trial Details

Trial ID

NCT04718168

Start Date

May 17 2021

End Date

September 1 2026

Last Update

January 16 2025

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

University of California - San Diego

San Diego, California, United States, 92093

2

Institute of Esophageal and Reflux Surgery

Denver, Colorado, United States, 80124

3

Sarasota Memorial HealthCare System

Sarasota, Florida, United States, 34239

4

Northshore University Health System Research Institute

Evanston, Illinois, United States, 60201