NL-OMON35885撤回2 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) - CS005, EndoStim Inc., Electrical Stimulation
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 8
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 21 - 65 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. Baseline GERD HRQL
- •heartburn score of >= 20 off PPI assessed during the run in phase.
- •c. Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or
- •II (or comparable local classification if any).
- •d. Subject has demonstrated satisfactory symptomatic response to a previous course of GERD
- •therapy (>= 2 weeks). GERD HRQL heartburn score improvement of > 10 on therapy as
- •assessed within 6 weeks of enrollment.
- •e. Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry of
- •antisecretory therapy performed within 6 months of enrollment; pH < 4 for > 5% of total time or >
- •3% of supine time.
- •f. Subject has a resting LES end expiratory pressure > 5mm Hg and < 15 mm Hg on a high
- •resolution manometry within 6 months of enrollment.
- •g. Subject has esophagitis <= Grade C (LA classification) on upper endoscopy within 6 months of
- •enrollment.
- •h. Subject has esophageal body contraction amplitude > 30 mmHg for >70% of swallows and >
- •50% peristaltic contractions on high resolution manometry.
- •i. Subject has signed the informed consent form.
排除标准
- •a. Subject has any non-GERD esophageal motility disorders.
- •b. Subject has gastroparesis.
- •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 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 esophageal or gastric surgery, including nissen fundoplication.
- •t. Subject has any condition that, at the discretion of the investigator or sponsor, would preclude
- •participation in the trial.
研究者
相似试验
已完成
2 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) (CS005)Heartburn10017977NL-OMON36042EndoStim30
已完成
3 期
Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERDCTRI/2012/05/002687Endostim Inc30
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)Gastroesophageal Reflux DiseaseHeartburn10017943NL-OMON42836Medisch Universitair Ziekenhuis Maastricht15
已完成
不适用
Effects of eccentric exercise on blood pressure in patients with hypertensiohypertension.Hypertensive diseasesI10-I15IRCT2014061618108N1Semnan University of Medical Sciences20
招募中
不适用
The effects of yoga and music on beta-endorphin, serotonin, body composition, anxiety and depression in obese obese womeIRCT20220304054178N1The University of Kordestan30