Cohort Registry on LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 336
- 试验地点
- 6
- 主要终点
- Incidence of Hiatal Hernia Recurrence
研究概览
简要总结
The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and Magnetic Sphincter Augmentation or fundoplication construction more than 2 years prior to initial study visit.
详细描述
The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and anti-reflux surgery with either Magnetic Sphincter Augmentation (MSA) using LINX placement or fundoplication construction more than 2 years prior to initial study visit. Subjects will be enrolled by invitation only by participating investigators. Enrollment will consist of 300 LINX MSA patients and 150 fundoplication patients with a total of 450 from 4 sites within the United States. Data will be collected for up to 6 years.The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo hiatal hernia repair of a large (>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who underwent hiatal hernia repair with fundoplication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 21 years of age and at least the minimum Age of Majority according to applicable state law.
- •Underwent primary index procedure of laparoscopic repair of a hiatal hernia larger than 3 cm with placement of a LINX® device or construction of a fundoplication for reflux control more than 2 years prior to his/her enrollment or has completed 1 or 2 of the barium swallows and GERD-HRQLs within study time points with or without hiatal hernia recurrence.
- •Subject is willing and able to cooperate with follow-up examinations.
- •Subject has been informed of the study procedures and treatment and has signed an informed consent.
排除标准
- •The surgical procedure was completed as an emergency procedure
- •Currently being treated with another investigational drug or investigational device
- •Suspected or confirmed esophageal or gastric cancer
- •Subject has Barrett's esophagus >3cm
- •Cannot understand trial requirements or is unable to comply with follow-up schedule
- •Pregnant or plans to become pregnant during the course of the study
- •Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
- •Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
研究组 & 干预措施
Prior Primary Large Hiatal Hernia with LINX Placement MSA
Patients who were previously implanted with the LINX device during repair of a hiatal hernia >3 cm >2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at 3 and 5 years to determine recurrence of hiatal hernia.
干预措施: LINX Reflux Management System (Device)
Prior Primary Large Hiatal Hernia with Fundoplication
Patients who previously underwent lower esophageal sphincter reconstruction by fundoplication during repair of a hiatal hernia >3 cm >2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at about 3 and 5 years to determine recurrence of hiatal hernia.
干预措施: Fundoplication (Procedure)
结局指标
主要结局
Incidence of Hiatal Hernia Recurrence
时间窗: Up to 5 years post index procedure
The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo primary hiatal hernia repair of a large (\>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who undergo hiatal hernia repair with fundoplication.
次要结局
- Incidence of Repeat Surgical Intervention(5 years)
- Understanding Patient Reported Symptom Control(5 years)