An Investigation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Endostim Inc
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is safety. Safety will be assessed by the incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period.
研究概览
简要总结
This study is a prospective, open label, multicenter, treatment trial to investigate the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD) that will be conducted on 30 patients in 8 countries (Chile, Colombia, Belgium, Germany, The Netherlands, Sweden, and India) over an eight-month period encompassing initiation of enrollment through six months follow up. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary safety endpoint will be assessed by incidence and severity of adverse events through 6 months follow-up. The secondary efficacy endpoint will be assessed by change in GERD symptoms, Lower Esophageal Sphincter End Expiratory Pressure, and Esophageal Acid Exposure over a period of six months from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject is between 21 – 70 years of age.
- •Subject has a history of heartburn, regurgitation or both for >12 month prompting physician recommendation of continual daily use of PPI before study entry.
- •Baseline GERD HRQL heartburn score ≥ 20 following 10-14 days off PPI and at least 10 points higher than the On PPI score -Subject who are on standard medical therapy for 12 months or longer and experience discomfort or who are otherwise dissatisfied with GERD symptoms -Subjects with a GERD condition that in the opinion of the PI justifies a minimally invasive reversible procedure prior to attempting anatomical change such as Nissen Fundoplication -Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or II (or comparable local classification if any).
- •Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry of antisecretory therapy performed within 6 months of screening visit; pH < 4 for > 5% of total time.
- •Subject has a resting LES end expiratory pressure ≥ 5mm Hg and ≤ 15 mmHg on a high resolution manometry within 6 months of enrollment.
- •Subject has esophagitis ≤ Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
- •Subject has esophageal body contraction amplitude > 30 mmHg for >50% of swallows and > 50% peristaltic contractions on high resolution manometry.
- •Subject has signed the informed consent form and is able to adhere to study visit schedule.
排除标准
- •Subject has any non-GERD esophageal motility disorders.
- •Subject has gastroparesis.
- •Subject has any significant multisystem diseases.
- •Subject has an autoimmune or a connective tissue disorder (e.g. scleroderma, dematomyositis, Calcinosis-Raynaud’s-Esophagus Sclerodactyly Syndrome (CREST), Sjogren’s Syndrome, Sharp’s Syndrome) requiring therapy in the preceding 2 years.
- •Subject has Barrett’s epithelium ( M2; C1) or any grade of dysplasia.
- •Subject has a hiatal hernia larger than 3 cm.
- •Subject has a body mass index (BMI) greater than 35 kg/m
- •Subject has Type 1 diabetes mellitus -Subject has uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c 9.5 in the previous 6 months, or has T2DM for 10 years.
- •Subject has a history of suspected or confirmed esophageal or gastric cancer.
- •Subject has esophageal or gastric varices.
- •Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
- •Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
- •Subject requires chronic anticoagulant therapy.
- •Subject has dysphagia or esophageal peptic stricture, excluding Schatzki’s ring.
- •Subject of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
- •Subject is currently enrolled in other potentially confounding research.
- •History of any malignancy in the last 2 years.
- •History of previous esophageal or gastric surgery, including nissen fundoplication.
- •Subject has any condition that, at the discretion of the investigator or sponsor, would preclude participation in the trial.
结局指标
主要结局
The primary endpoint of the study is safety. Safety will be assessed by the incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period.
时间窗: 2 week after implant, 1 month after implant, 2 months after implant, 3 month after the implant, 4 month after the implant, 5 month after the implant, 6 month after the implant.
次要结局
- The secondary endpoints are related to efficacy as measured by comparison of the following(Not Applicable)