GORE® ENFORM Biomaterial Product Study

Part of paid clinical trials in San Diego, California.

Sponsor
W.L.Gore & Associates
Study ID
NCT04718168
Status
Recruiting
Apply to this trial

Conditions

  • Hernia, Diaphragmatic
  • Hernia, Hiatal
  • Hernia, Ventral
  • Incisional Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gore ENFORM Biomaterial (Preperitoneal) — DEVICE
    ENFORM Biomaterial bioabsorbable hernia mesh
  • Gore ENFORM Biomaterial (Intraperitoneal) — DEVICE
    ENFORM Biomaterial bioabsorbable hernia mesh

Study Details

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.

Key Dates

Start date
May 17, 2021
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
245 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial
  • Experimental: Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial
  • Experimental: Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial
  • Experimental: Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial

Primary Outcome Measure

Hernia Recurrence - Primary Device Endpoint [ Time Frame: Through 24 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of California - San DiegoSan DiegoCalifornia92093
Graham J. Spurzem, MD
[email protected]
831-537-8815
Ryan Broderick, MD (PRINCIPAL_INVESTIGATOR)
Hannah Hollandsworth, MD (SUB_INVESTIGATOR)
Institute of Esophageal and Reflux SurgeryDenverColorado80124
Philip Woodworth, MD (PRINCIPAL_INVESTIGATOR)
Sarasota Memorial HealthCare SystemSarasotaFlorida34239
Kristen McKenzie, BSN, RN
[email protected]
941-917-1211
Jonathan Yunis, MD (PRINCIPAL_INVESTIGATOR)
Northshore University Health System Research InstituteEvanstonIllinois60201
JoAnn Carbray, CCRP
[email protected]
847-570-3802
Michael Ujiki, MD (PRINCIPAL_INVESTIGATOR)
John Linn, MD (SUB_INVESTIGATOR)
University of KentuckyLexingtonKentucky40506
Anna Rockich, PharmD
[email protected]
610-212-1086
Sydney Cloyd, RN, BSN
[email protected]
859-218-5151
John Roth, MD (PRINCIPAL_INVESTIGATOR)
Atrium HealthCharlotteNorth Carolina28204
Greg Scarola, MS
[email protected]
704-355-5766
Todd Heniford, MD (PRINCIPAL_INVESTIGATOR)
Prisma Health - UpstateGreenvilleSouth Carolina29615
Abby Birrell
[email protected]
864-522-2117
Jeremy Warren, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at HousonHoustonTexas77401
Elaine Tran
[email protected]
713-486-1346
Angilyn R. Rivera
[email protected]
713-486-1350
Julie Holihan, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Krissa Packard, MS, ACRP-CP
[email protected]
414-955-1861
Matthew Goldblatt, MD (PRINCIPAL_INVESTIGATOR)

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University of California - San Diego· San Diego, CAInstitute of Esophageal and Reflux Surgery· Denver, COSarasota Memorial HealthCare System· Sarasota, FLNorthshore University Health System Research Institute· Evanston, ILUniversity of Kentucky· Lexington, KYAtrium Health· Charlotte, NC

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