GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 245
- 试验地点
- 10
- 主要终点
- Hernia Recurrence - Primary Device Endpoint
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
- •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.
- •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).
- •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.
- •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.
研究组 & 干预措施
Ventral/Incisional Hernia - Preperitoneal ENFORM Biomaterial
干预措施: Gore ENFORM Biomaterial (Preperitoneal) (Device)
Ventral/Incisional Hernia - Intraperitoneal ENFORM Biomaterial
干预措施: Gore ENFORM Biomaterial (Intraperitoneal) (Device)
Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM Biomaterial
干预措施: Gore ENFORM Biomaterial (Preperitoneal) (Device)
Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM Biomaterial
干预措施: Gore ENFORM Biomaterial (Intraperitoneal) (Device)
结局指标
主要结局
Hernia Recurrence - Primary Device Endpoint
时间窗: Through 24 months
Clinical diagnosed hernia recurrence in the area of the initial hernia repair (within device overlap at time of index procedure).
Incidence of SSOPI - Primary Procedural Endpoint 3
时间窗: First Post-Procedural Visit (Days 1-45)
Incidence of SSOPI, reported as a composite and individually.
Incidence of SSI - Primary Procedural Endpoint 1
时间窗: First Post-Procedural Visit (Days 1-45)
Incidence of SSI, reported as a composite and individually.
Incidence of SSO - Primary Procedural Endpoint 2
时间窗: First Post-Procedural Visit (Days 1-45)
Incidence of SSO, reported as a composite and individually.
次要结局
- Freedom from potential device-related SAEs - Secondary endpoint 1(Through 24 months)
- Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3(Through 24 months)
- Relief from GERD Symptoms - Secondary Endpoint 4(Through 24 months)
- Re-intervention at study-treated location - Secondary Endpoint 2(Through 24 months)