Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
研究概览
简要总结
The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.
详细描述
This retrospective, open-label, post-market study evaluates the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States, in clinical routine practice, as standard of care.
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
- •Age 18-85 years
- •Have undergone the TIF procedure within the past 2 years
- •History of daily proton pump inhibitor (PPI) use for >6 months
- •Proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (pH) or moderate to severe symptoms on or off PPIs
- •Deteriorated gastroesophageal junction (Hill grade II or III)
- •Availability for a follow-up visit at 6,12 or 24 months
- •Willingly and cognitively signed informed consent
排除标准
- •Procedure not completed or performed following a non-standardized TIF protocol
- •Subjects suffering from other gastrointestinal (GI) conditions such as dyspepsia, celiac disease, Irritable bowel syndrome (IBS) or Crohn's disease
- •Pregnancy
- •Enrollment in another device or drug study that may confound the results
结局指标
主要结局
Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
时间窗: median 7 months (range 5-17 months)
Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of \<18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of \< or = 13) questionnaires) at the follow-up.
次要结局
- Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use(median 7 months (range 5-17 months))
- Number of Participants With Healing of Reflux Esophagitis(median 7 months (range 5-17 months))
- Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)(median 7 months (range 5-17 months))
- Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes(median 7 months (range 5-17 months))
- Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up(median 7 months (range 5-17 months))