NCT01574339已完成不适用
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)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
The EndoStim LES Stimulation System is an investigational device intended to improve the LES pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from Gastroesophageal Reflux Disease (GERD).
详细描述
EndoStim has developed an investigational medical device specifically designed to deliver electrical stimulation to the LES and has completed two clinical feasibility studies using an external version of the EndoStim stimulation system in fifteen subjects. In these two short-term studies, electrical stimulation resulted in significant increases in LES pressure.
This study will further evaluate the safety of the procedure and its feasibility for use in this group of patients.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 following 10-14 days off PPI which is ≥ 20 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 pHmetry 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 mm Hg 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, dermatomyositis, 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.
研究组 & 干预措施
Treatment Arm
Experimental
EndoStim LES Stimulation System
干预措施: EndoStim LES Stimulation System (Device)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: 24 months
Safety will be assessed by incidence and severity of adverse events through 24 months of follow-up.
次要结局
- Change in GERD-HRQL(Change in GERD-HRQL and RDQ questionnaire score when available from baseline (as measured off PPI) to 1, 3, 6, 12, 18 and 24 months. Heartburn and regurgitation scores will be calculated separately.)
- Change in GERD symptoms(Changes in GERD symptoms as measured by the patient daily symptom-diary at 3, 6, 12, 18 and 24 months Vs. baseline.)
- Change in LES pressure(Baseline LES end expiratory pressure (LESPpre) will be compared with the end expiratory pressure (LESPpost) at 3 and 6 months.)
- Change in GI symptoms(Symptoms will be compared between baseline (as measured while on and off PPI) to 1, 3, 6, 12, 18 and 24 months.)
- Change in esophageal acid exposure(Number of reflux events >5 minutes will be compared between baseline and 3, 6, 12 and 24 months.)
- Change in medication usage(The use of antisecretory medication will be compared between baseline and 3, 6, 12, 18 and 24 months.)
- Change in sleep-related quality of life(Baseline and 6, 12, and 24 months scores of Sleep quality questionnaire.)
- Change in work productivity(Baseline and 6, 12, and 24 months scores of Sleep quality and Work productivity questionnaires)
研究者
研究点 (14)
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