NL-OMON40981已完成2 期
An Investigation of Electrical Stimulation on Gastroesophageal Reflux Disease (GERD) in Patients After Sleeve Gastrectomy - The effect of EST on GERD after sleeve gastrectomy
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •a. Subject is between 18 * 80 years of age.
- •b. Subject underwent a sleeve gastrectomy minimum one year prior to enrollment (in order to have reached a stable weight loss plateau).
- •c. Subject has a history of heartburn, regurgitation or both for >6 month prompting physician recommendation of continual daily use of PPI after sleeve gastrectomy.
- •d. Baseline off-PPI GERD-HRQL score * 20 following 10-14 days off PPI
- •e. Baseline off-PPI GERD-HRQLscore is at least 5 points higher than the on-PPI score or a positive relationship between the occurrence of their primary symptom during the pH impedance monitoring (symptom association probability * 95% or a SI score * 50%) is present.
- •f. Subject who are on standard medical therapy for 6 months or longer and experience discomfort or who are otherwise dissatisfied with GERD symptoms.
- •g. Subjects with a GERD condition that in the opinion of the PI justifies a minimally invasive reversible procedure prior to attempting a more drastic procedure such as a gastric bypass.
- •h. 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 > 6% of total time.
- •i. Subject has a resting LES end expiratory pressure * 5mmHg on manometry performed within 6 months of enrollment.
- •j. Subject has no esophagitis or esophagitis * Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
- •k. Subject has esophageal body contraction amplitude > 30 mmHg for >30% of swallows and > 30% peristaltic contractions on manometry.
- •l. Subject has signed the informed consent form and is able to adhere to study visit schedule.
排除标准
- •a. Subject has any non-GERD esophageal motility disorders.
- •b. Subject has evidence of obstruction or stricture in the gastric sleeve by a barium swallow and endoscopy.
- •c. Subject has any significant multisystem diseases.
- •d. 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.
- •e. Subject has Barrett*s epithelium (> M2; >C1) or any grade of dysplasia.
- •f. Subject has a hiatal hernia larger than 3 cm.
- •g. Subject has a body mass index (BMI) greater than 35 kg/m2.
- •h. Subject has Type 1 Diabetes Mellitus
- •i. Subject has uncontrolled Type 2 Diabetes Mellitus (T2DM) defined as HbA1c >9.5 in the previous 6 months, or has T2DM for > 10 years.
- •j. Subject has a history of suspected or confirmed esophageal or gastric cancer.
- •k. Subject has esophageal or gastric varices.
- •l. Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
- •m. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
- •n. Subject requires chronic anticoagulant therapy.
- •o. Subject has dysphagia or esophageal peptic stricture, excluding Schatzki*s ring.
- •p. Subject of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
- •q. Subject is currently enrolled in other potentially confounding research.
- •r. History of any malignancy in the last 2 years.
- •s. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
- •t. Weight change of +/- 10% of the EWL (Excess Weight Loss) in the 3 months prior to enrollment.
研究者
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