Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm
研究概览
简要总结
The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (>5cm) or paraesophageal hernias when Ovitex LPR mesh used during the repair.
详细描述
This is an investigator initiated, single site, single arm study investigating the recurrence rate of hiatal hernia and safety using Ovitex LPR in patients undergoing hiatal hernia repair.
Ovitex LPR mesh is a reinforced tissue matrix, comprised of a fine non-absorbable polymer suture interwoven through layers of absorbable biologic material in a "lockstitch" pattern.The biologic material in OviTex, derived from ovine rumen (sheep stomach), serves as the natural building block and is optimized to reduce foreign body response, enable functional tissue remodeling and promote a more natural hernia repair. The interwoven polymer fibers provide additional reinforcement, along with improved handling and load-sharing capability. The permanent polymer fiber (polypropylene) is a standard surgical suture material that is used in hiatal hernia surgery and comprises less than 5% of the final product.
Preop details, quality of life questionnaires and surgery details will be collected along with post op GERD (gastro esophageal reflux disease) quality of life questionnaires and barium swallow esophagrams to objectively examine recurrence of hiatal hernia at 1, 3, and 5 years post op. Data will be carefully collected and reviewed for discrepancies and verified with source prior to analysis.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 year old with PEH and appropriate surgical indication for repair
排除标准
- •Under 22 years of age.
- •In need of an emergency procedure.
- •Currently being treated with another investigational drug or device.
- •Have had prior gastric or esophageal surgery.
- •Have had any previous intervention for GERD.
- •Are suspected or confirmed to have esophageal or gastric cancer.
- •Have a Body Mass Index (BMI) greater than
- •Cannot understand trial requirements or are unable to comply with follow-up schedule.
- •Are pregnant, nursing, or plan to become pregnant.
- •Have a mental health disorder that would interfere with your ability to follow study instructions.
- •Have suspected or known allergies to Ovitex
- •Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.
研究组 & 干预措施
Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair
This is a single arm, open label, nonrandomized study evaluating 100 subjects diagnosed with a paraesophageal or large hiatal hernia planning to undergo surgical repair with the study investigators.
干预措施: Ovitex LPR (Device)
结局指标
主要结局
Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm
时间窗: 5 years
Assess recurrence rates by objective measures when Ovitex LPR permanent polypropylene polymer reinforcement (Ovitex LPR) is placed during robotic-assisted repair of paraesophageal and large (\> 5cm) hiatal hernias (henceforth PEH) using recurrence rate measurements defined as \> 2cm axial hernia by Barium Swallow or endoscopy, if available
次要结局
- Number of participants with treatment related mesh erosions as assessed by study quality of life questionnaire leading to endoscopy(5 years)