Health TrialsbyHealthPanel

GORE® ENFORM Biomaterial Product Study

ConditionsHernia, VentralHernia, HiatalHernia, DiaphragmaticIncisional Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorW.L.Gore & Associates

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gore ENFORM Biomaterial (Preperitoneal)

    Device

    ENFORM Biomaterial bioabsorbable hernia mesh

  • Gore ENFORM Biomaterial (Intraperitoneal)

    Device

    ENFORM Biomaterial bioabsorbable hernia mesh

Treatment groups

245 Participants
are divided into 4 treatment groups
Group A: Ventral/Incisional Hernia - Preperitoneal ENFORM BiomaterialExperimental treatment 1 intervention
Group B: Ventral/Incisional Hernia - Intraperitoneal ENFORM BiomaterialExperimental treatment 1 intervention
Group C: Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM BiomaterialExperimental treatment 1 intervention
Group D: Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM BiomaterialExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hernia Recurrence - Primary Device Endpoint

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

Time frame
Through 24 months
2

Incidence of SSI - Primary Procedural Endpoint 1

Incidence of SSI, reported as a composite and individually.

Time frame
First Post-Procedural Visit (Days 1-45)
3

Incidence of SSO - Primary Procedural Endpoint 2

Incidence of SSO, reported as a composite and individually.

Time frame
First Post-Procedural Visit (Days 1-45)
4

Incidence of SSOPI - Primary Procedural Endpoint 3

Incidence of SSOPI, reported as a composite and individually.

Time frame
First Post-Procedural Visit (Days 1-45)

Secondary outcomes

1

Freedom from potential device-related SAEs - Secondary endpoint 1

Freedom from potential device-related Serious Adverse Events will be reported descriptively with no formal goals or hypothesis.

Time frame
Through 24 months
2

Re-intervention at study-treated location - Secondary Endpoint 2

Surgical re-intervention in the area of the hernia repaired initially (e.g. drain insertion, infection, surface issues, second operation, etc.) will be reported descriptively with no formal goals or hypothesis.

Time frame
Through 24 months
3

Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3

For ventral hernia subjects; change in Quality of Life in Carolinas Comfort Scale as measured by a change in total score of the Carolinas Comfort Scale Quality of Life questionnaire given at follow-up visits. Minimum Total Score is 0 and maximum Total Score is 115. Lower score means better outcome.

Time frame
Through 24 months
4

Relief from GERD Symptoms - Secondary Endpoint 4

For diaphragmatic hernia subjects; relief from GERD symptoms as measured by a decrease in the total score of the Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire given at follow-up visits. Total Score: Calculated by summing the individual scores to questions 1-15. Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6. Worst heartburn symptoms = 30 No heartburn symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions 10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.

Time frame
Through 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

W.L.Gore & Associates

Lead sponsor

Source ClinicalTrials.gov
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