CTRI/2012/05/002687已完成3 期
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) - NA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Endostim Inc
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subject is between 21 â?? 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-Raynaudâ??s-Esophagus Sclerodactyly Syndrome (CREST), Sjogrenâ??s Syndrome, Sharpâ??s Syndrome) requiring therapy in the preceding 2 years.
- •-Subject has Barrettâ??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/m2.
- •-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 Schatzkiâ??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.
研究者
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