NL-OMON42836撤回2 期
An investigation of the Effect of Long-Term Electrical Stimulation on Esophageal Acid Exposure in Pediatric Patients with Gastroesophageal Reflux Disease (GERD) - Effect of electrical stimulation on GERD in pediatric patients.
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 15
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
- 2 至 17（—）
入选标准
- •a) Subject is between 5 * 16 years of age.
- •b) Subject has a history of heartburn, regurgitation or both for >6 month prompting physician recommendation of continual daily use of PPI before study entry.
- •c) Subject who are on standard medical therapy for 6 months or longer and experience discomfort or who are otherwise dissatisfied with GERD symptoms.
- •d) 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 or Toupet fundoplication.
- •e) 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.
- •f) Subject has a resting LES end expiratory pressure * 5mmHg on manometry performed within 6 months of enrollment.
- •g) Subject has no esophagitis or esophagitis * Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
- •h) Subject*s body weight >15kg.
- •i) Subject*s BMI <30 kg/m2.
- •j) Subject*s parent or legal guardian (and subject from age 12) has signed the informed consent form and is able to adhere to study visit schedule.
排除标准
- •a) Subject has known non-GERD esophageal motility disorder that in the opinion of investigator precludes an anti-reflux procedure.
- •b) Subject has history of gastroparesis.
- •c) Subject has any history of significant multisystem diseases (e.g. kidney failure, liver failure).
- •d) Subject has a known 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 30 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 due to eosinophilic esophagitis, 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) History of previous surgery involving the LES, excluding Nissen and Toupet fundoplication.
- •t) 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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