NCT02505945已完成4 期
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
Torax Medical Incorporated21 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 21
- 主要终点
- Elimination of Moderate-severe Regurgitation at 6 Months
研究概览
简要总结
This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD).
详细描述
Prospective, multicenter, 2:1 randomized, cross-over, two arms
- Control arm: Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
- Treatment arm: LINX Reflux Management System Up to 20 study centers throughout the U.S. will participate. Approximately150 patients will be enrolled into the study. Subjects will be randomized 2:1 into the double-dose PPIs arm (100 subjects) and the LINX arm (50 subjects).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient seeks consultation for lack of satisfactory symptom response to once daily PPIs.
- •Age≥ 21 years old.
- •Abnormal distal esophageal pH determined by total % time pH <4 or DeMeester Score. Testing to be completed off GERD medications for at least 7 days, with the exception of antacids, which may be taken up until the morning of assessment.
- •Suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery).
- •Patient has provided written informed consent for participation in the randomized study.
排除标准
- •Currently taking double-dose PPIs (twice daily dosing).
- •Hiatal hernia >3cm as determined by endoscopy.
- •Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.
- •Esophagitis Grade C or D (Los Angeles classification).
- •Body mass index >
- •Diagnosed with an esophageal motility disorder LES.
- •Esophageal stricture or gross esophageal anatomic abnormalities
- •History of/or known Barrett's esophagus.
- •Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.
研究组 & 干预措施
Control Arm
Active Comparator
Double-dose PPI [Omeprazole 20 mg BID (twice a day)]
干预措施: Omeprazole (Drug)
Treatment Arm
Active Comparator
LINX Reflux Management System
干预措施: LINX Reflux Management System (Device)
结局指标
主要结局
Elimination of Moderate-severe Regurgitation at 6 Months
时间窗: 6 months
The primary endpoint was the percent of patients in both treatment arms who achieved elimination of moderate-severe regurgitation at 6 months, as reported on the foregut symptom questionnaire.
次要结局
- Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores(6 months)
研究者
研究点 (21)
Loading locations...
相似试验
已完成
不适用
Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary StricturesEndoscopic Retrograde Cholangiopancreatography (ERCP)Miniforceps BiopsyBiliary StricturesBrush CytologyNCT06612931Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine112
Unknown
不适用
Study to Compare Two Functional Appliances for Class II MalocclusionsMalocclusion, Angle Class IINCT03773783University of Birmingham64
终止
不适用
Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)Weight LossNCT01497028Jacksonville Surgical Associates
Unknown
4 期
Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus AnesthesiologistPain, PostoperativeSatisfactionNCT03864588Rothman Institute Orthopaedics164
Unknown
不适用
The Research of the Evaluation of Clinical Procedures in Gastroesophageal Varices in Patients With Liver CirrhosisGastroesophageal VariceNCT01592578Shanghai Zhongshan Hospital96