GORE® ENFORM Biomaterial Product Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Hernia Recurrence - Primary Device Endpoint [Срок оценки: Through 24 months]
• Incidence of SSI - Primary Procedural Endpoint 1 [Срок оценки: First Post-Procedural Visit (Days 1-45)]
• Incidence of SSO - Primary Procedural Endpoint 2 [Срок оценки: First Post-Procedural Visit (Days 1-45)]
• Incidence of SSOPI - Primary Procedural Endpoint 3 [Срок оценки: First Post-Procedural Visit (Days 1-45)]

Вторичные конечные точки (4)

• Freedom from potential device-related SAEs - Secondary endpoint 1 [Срок оценки: Through 24 months]
• Re-intervention at study-treated location - Secondary Endpoint 2 [Срок оценки: Through 24 months]
• Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3 [Срок оценки: Through 24 months]
• Relief from GERD Symptoms - Secondary Endpoint 4 [Срок оценки: Through 24 months]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• 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
• … и ещё 1 центр

Идентификаторы

NCT: NCT04718168 · ENF 18-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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