A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tela Bio Inc
- 入组人数
- 173
- 试验地点
- 6
- 主要终点
- Hernia recurrence
研究概览
简要总结
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
详细描述
This prospective, open-label, multicenter, non-randomized, post-market study will enroll up to 173 subjects in the United States. Patients undergoing an elective hiatal hernia repair and who meet all eligibility criteria will be enrolled in the study. Subjects will undergo minimally invasive procedures for hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable for reinforcement. Subjects will have clinical follow-up through 5 years. Data collected in this study will be compared to a literature control at 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a candidate for an elective robotic or laparoscopic primary hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable.
- •Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.
- •Patient is at least 22 years old at the time of surgery.
- •Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years).
- •Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.
排除标准
- •(Baseline):
- •Patient has a Body Mass Index (BMI) of ≥
- •Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.
- •Patient has a Type I hiatal hernia (defined as only the esophagogastric junction is above the diaphragm).
- •Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.
- •Patient is a current nicotine user (including smokeless, vaporized, etc.)
- •Patient has a history of illicit drug or alcohol abuse (in the last three years).
- •Patient has an allergy to ovine-derived products or a known sensitivity to polyglycolic acid (PGA).
- •Patient has an allergy to barium.
- •Patient's surgery will include the use of an anti-reflux implantable device (LINX, etc.).
- •Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.
- •Patient has participated in another gastrointestinal (GI) clinical study within the past 30 days or is currently involved in another clinical study excluding observational and registry studies.
- •Patient had previous surgery at the gastroesophageal junction.
- •Patient had a prior hiatal hernia repair.
- •Patient has an incarcerated hernia that requires emergent intervention.
- •Patient is a prisoner.
- •Exclusion Criteria (Intra-operative):
- •Patient is unable to receive OviTex Core Resorbable or OviTex 1S Resorbable at time of surgery.
- •Surgery requires the use of an additional mesh device or a pledget for reinforcement.
- •Surgery includes the use of an anti-reflux implantable device (LINX, etc.).
- •Surgery performed as an open procedure.
- •Patient has a condition, which in the Investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's participation in the study.
研究组 & 干预措施
OviTex Reinforced Tissue Matrix
This is a single-arm study. All study subjects will receive OviTex.
干预措施: OviTex Reinforced Tissue Matrix (Device)
结局指标
主要结局
Hernia recurrence
时间窗: At 24 months
Incidence of radiographic recurrence at 24 months, defined as \> 2cm above the hiatus via barium swallow.
次要结局
- Early post-operative complications(Occurring within the first 3 months of the hiatal hernia repair)