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Recruiting NCT04718168

GORE® ENFORM Biomaterial Product Study

No phase Interventional Hernia, Ventral Hernia, Hiatal Hernia, Diaphragmatic Incisional Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal).
Who it may be relevant to
Registry conditions: Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and long-term follow up.

Interventions

  • Device Gore ENFORM Biomaterial (Preperitoneal)
    ENFORM Biomaterial bioabsorbable hernia mesh
  • Device Gore ENFORM Biomaterial (Intraperitoneal)
    ENFORM Biomaterial bioabsorbable hernia mesh

Primary outcome measures

  • Hernia Recurrence - Primary Device Endpoint [Time frame: Through 24 months]
  • Incidence of SSI - Primary Procedural Endpoint 1 [Time frame: First Post-Procedural Visit (Days 1-45)]
  • Incidence of SSO - Primary Procedural Endpoint 2 [Time frame: First Post-Procedural Visit (Days 1-45)]
  • Incidence of SSOPI - Primary Procedural Endpoint 3 [Time frame: First Post-Procedural Visit (Days 1-45)]
Secondary outcome measures (4)
  • Freedom from potential device-related SAEs - Secondary endpoint 1 [Time frame: Through 24 months]
  • Re-intervention at study-treated location - Secondary Endpoint 2 [Time frame: Through 24 months]
  • Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3 [Time frame: Through 24 months]
  • Relief from GERD Symptoms - Secondary Endpoint 4 [Time frame: Through 24 months]

Eligibility criteria

Pre-procedure Inclusion Criteria:

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 Criteria:

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • University of California - San Diego — San Diego
  • Institute of Esophageal and Reflux Surgery — Denver
  • Sarasota Memorial HealthCare System — Sarasota
  • Northshore University Health System Research Institute — Evanston
  • University of Kentucky — Lexington
  • Atrium Health — Charlotte
  • Prisma Health - Upstate — Greenville
  • University of Texas Health Science Center at Houson — Houston
  • … and 1 more center

Identifiers

NCT: NCT04718168 · ENF 18-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗