NCT03280121终止不适用
Hernia Reduction Prior to Scheduled TIF Completion- The HEURISTIC Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- pH Study
研究概览
简要总结
Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device
详细描述
Evaluation of the relative merits, safety and effectiveness of the EsophyX ZR transoral device in performing the standardized TIF 2.0 procedure preceded by laparoscopic Hiatal Hernia repair in PPI-prescribed patients with persistent "troublesome symptoms" per the Montreal consensus definition
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-72 years
- •Dependent upon daily PPIs for > 6 months. Daily use is defined as a double dose, or full dose or half dose taken daily for more than 80% of the total number of days during the proceeding evaluation period
- •Troublesome symptoms, specifically heartburn or regurgitation, while on optimized dose of PPI's Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2 days a week and are mild to severe in severity
- •Abnormal ambulatory (Bravo) pH study after off PPI therapy for 7 days, i.e. > 5.3% of the time with pH < 4 in a 48-hour monitoring period
- •Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as required)
- •Pre-enrollment Hiatal Hernia (axial height and transverse dimension) from > 2 cm up to 4 cm inclusive.
- •Patient willing to cooperate with post-operative dietary recommendations and assessment tests at the requisite follow-up visits
- •Signed informed consent Exclusion Criteria
- •Hiatal hernia ≤ 2 and > 4 cm
- •Esophagitis Los Angeles grade C or D
- •Esophageal ulcer
- •Esophageal stricture
- •Long-segment Barretts esophagus (Prague: C > 1, M > 3)
- •Esophageal motility disorder
- •Pregnancy or plans for pregnancy in the next 12 months (in females)
- •Immunosuppression
- •Portal hypertension and/or varices
- •History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
- •Active gastro-duodenal ulcer disease
- •Gastric outlet obstruction or stenosis
- •Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
- •Coagulation disorders
- •Atypical symptoms including gas bloat and dysphagia.
- •Any other presenting condition that in the opinion of the investigator would not make participation in this study in the patient's best interest.
- •Post Enrollment Exclusion -
- •Inability to repair Hiatal hernia with at least 2cm of intra-abdominal esophagus length.
排除标准
- 未提供
结局指标
主要结局
pH Study
时间窗: 48 hour monitoring period
Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH \< 4 in
次要结局
- Number of Participants With a Change in Troublesome Symptoms From Baseline(6 months)
- Number of Participants With a Change in PPI Consumption From Baseline to 6 Months(6 months)
研究者
研究点 (6)
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