A 12-month Double-blind, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Efficacy of Endoluminal Aluvra™ for the Treatment of Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Efficacy of Aluvra- GERD HRQL
研究概览
简要总结
This is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of heartburn-like pain, regurgitation, or both prior to the initiation of proton pump inhibitor (PPIs) therapy.
- •History of GERD symptoms of at least six months despite continuous PPIs.
- •GERD-HRQL score ≥15 after discontinuing PPI therapy.
- •GERD-HRQL score improvement of at least 6 points while on PPIs, with at least 4-point improvement in heartburn subscore.
- •A minimum GERD-HRQL score while on PPIs of
- •Pathologic acid exposure time, a baseline pH <4.0 for ≥ 5.3% of time during a 48-hour evaluation period.
- •Twenty two years of age or older.
- •Life expectancy of at least two years.
- •Willing and able to return to the clinic or hospital for all evaluation procedures scheduled throughout the course of this study.
- •Is capable of understanding clinical study procedures and giving informed consent.
排除标准
- •Unable to tolerate an endoscopic procedure
- •Presence of esophageal or gastric varices
- •Presence of erosive esophagitis (LA Classification of C or D)
- •Presence of a hiatal hernia > 2 cm
- •Presence of Barrett's esophagus
- •Presence of esophageal motility disorder
- •History of or known esophageal stricture or gross esophageal anatomic abnormalities
- •Symptoms of dysphagia more than once per week within the last six months
- •Obesity (BMI ≥ 35)
- •Gastric or esophageal cancer undergoing active treatment
- •Received radiation therapy to the esophagus and has fibrosis of the tissue at the likely injection sites
- •Had an ablation procedure in the lower esophageal sphincter area
- •Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use, uncontrolled diabetes or autoimmune disorder
- •Enrolled in a concurrent clinical trial
- •Inability to comply with study protocol due to a chronic disease, psychiatric illness, alcoholism, drug abuse, or geographic distance (as determined by investigator)
- •Pregnant and/or given birth in the previous twelve months or who plan to become pregnant in the next twelve months
- •Prior gastric or GERD surgery
研究组 & 干预措施
Aluvra™
Endoscopic injection of bulking agent (Aluvra) to the lower esophageal sphincter
干预措施: Aluvra™ (Device)
Saline
Endoscopic injection of saline
干预措施: Saline (Drug)
结局指标
主要结局
Efficacy of Aluvra- GERD HRQL
时间窗: 12 months
Efficacy will be established through two co-primary objectives. The first co-primary endpoint will be to compare response rates between treatment group and control group at 12 months based on the GERD-Health Related Quality of Life questionnaire.
Efficacy of Aluvra- Esophageal PH
时间窗: 12 months
Efficacy will be established through two co-primary objectives. The second co-primary endpoint will be to compare change from baseline in total percent time esophageal pH \<4 between the treatment group vs. the sham control group at 12 months.
次要结局
未报告次要终点